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result(s) for
"guided periodontal tissue regeneration"
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Periodontal regenerative therapy using recombinant human fibroblast growth factor (rhFGF)-2 in combination with carbonate apatite granules or rhFGF-2 alone: 12-month randomized controlled trial
by
Bizenjima, Takahiro
,
Ambiru, Mayuri
,
Murakami, Tasuku
in
Adult
,
Aged
,
Alveolar Bone Loss - surgery
2024
Objectives
This randomized controlled trial compared the outcomes of recombinant human fibroblast growth factor (rhFGF)-2 plus carbonate apatite (CO
3
Ap) granules with rhFGF-2 alone in the treatment of intrabony periodontal defects.
Materials and methods
Patients with Stage III Grade B/C periodontitis who had completed initial periodontal therapy and had intrabony defects with a depth of ≥ 3 mm were included. Defects were treated solely with rhFGF-2 (control) or rhFGF-2 plus CO
3
Ap (test). Periodontal parameters and a patient-reported outcome measure (PROM) were assessed at baseline, at 6, 9 and 12 months postoperatively. The primary outcome was the change in clinical attachment level (CAL) from baseline to 12 months postoperatively. Using the Friedman test with Dunn’s post-test, intragroup data were compared over time, and Mann-Whitney
U
test was used to assess intergroup data at each time point.
Results
Forty-eight sites in 38 patients were subjected to analysis. At 12 months postoperatively, CAL in both groups showed a significant improvement from baseline (
p
< 0.001). CAL gain was 3.4 ± 1.3 mm in the test group and 3.2 ± 1.2 mm in the control group, with no significant intergroup difference (
p
= 0.567). Radiographic bone fill in the test group (67.2%) was significantly greater than in the control group (32.4%) (
p
< 0.001). PROM scores showed no difference between groups.
Conclusions
At 12 months, the outcomes including CAL gain and PROM showed no significant differences between groups, although the combination treatment enhanced radiographic bone fill.
Clinical relevance
The use of rhFGF-2 (with/without CO
3
Ap) could lead to significant improvement in clinical parameters in the treatment of intrabony periodontal defects. The benefit of adding CO
3
Ap to rhFGF-2 therapy needs further evaluation.
Clinical Trial Registration Number
The University Hospital Medical Information Network-Clinical Trials Registry (UMIN-CTR) : UMIN000040783.
Journal Article
Comparative evaluation of demineralized freeze-dried bone allograft with and without concentrated growth factor membrane in the treatment of periodontal intrabony defects: a randomized controlled clinical trial
2023
BackgroundThe current study’s aim was to evaluate and compare demineralized freeze-dried bone allograft (DFDBA) with and without concentrated growth factor (CGF) membrane in the treatment of periodontal intrabony defects on both a clinical and radiographic level.Methods30 stage III grade B periodontitis patients with bilateral intrabony defects were involved in the split mouth randomized controlled trial, and they received either DFDBA alone (control group) or DFDBA plus CGF membrane treatment (test group). At baseline and 6 and 12 months, the gingival index (GI), plaque index (PI), probing pocket depth (PPD), clinical attachment level (CAL), and gingival recession (GR) were assessed, whereas cone beam computed tomography was used to assess the bone defect height (BDH), vertical bone loss (VBL), bone defect depth (BDD), mesio-distal bone defect width (MDBDW), bucco-lingual bone defect width (BLBDW), and bone defect volume (CBCT) at baseline and 12 months.ResultsThe radiographic measures BDH, BDD, MDBDW, BLBDW, and BDV in the test group likewise showed a higher reduction in PPD and gain in CAL than the control group. The results of the intergroup comparison showed that the test group had statistically significant differences in BDH, BDD, and MDBDW.ConclusionThe data show that the test group achieved better results, with greater reductions in PPD, gains in CAL, and decreases in BDH, BDD, MDBDW, BLBDW, and BDV.Clinical relevanceThe use of concentrated growth factor in conjunction with demineralized freeze-dried bone allograft may be suggested for the treatment of periodontal intrabony defects.
Journal Article
Efficacy of different forms of concentrated growth factors combined with deproteinized bovine bone minerals in guided bone regeneration: a randomized clinical trial
Objectives
To explore the bone regeneration effect of different forms of concentrated growth factor (CGF) when combined with deproteinized bovine bone mineral (DBBM) for simultaneous implant-guided bone regeneration (GBR) and its impact on postoperative adverse reactions.
Methods
Fifty-seven patients who underwent simultaneous implant GBR were selected for the study and divided into three groups. The study involved three groups: the gel phase concentrated growth factor (GPCGF) group, which used GPCGF-DBBM mixture; the liquid phase concentrated growth factor (LPCGF) group, which used LPCGF-DBBM mixture; and the control group, which used DBBM alone. The thickness of the buccal lateral bones was measured using cone beam computed tomography (CBCT), and patients were asked to complete questionnaires to assess primary adverse reactions during the first week after surgery. The data were analyzed using one-way ANOVA, Tukey test, and Kruskal-Wallis test.
Results
The buccal lateral bone thickness in the GPCGF, LPCGF, and control groups decreased significantly at 6 months post-surgery compared to immediately after surgery. The change of bone thickness in the GPCGF group was lower than that in the control group (
p
< 0.01), and that in the LPCGF group did not differ from that in the control group (
p
> 0.05). During the postoperative week, statistically significant differences could be observed in bleeding, mouth opening, chewing, sleeping, speaking, daily routine, and pain (
p
< 0.05).
Conclusions
Compared to the DBBM applied alone, the GPCGF-DBBM mixture has more positive implications for reducing bone resorption, promoting bone reconstruction and relieving certain postoperative adverse effects in dental implants with simultaneous GBR. The GPCGF-DBBM mixture was superior to the LPCGF-DBBM mixture in alleviating adverse effects in terms of bleeding and speaking after GBR.
Clinical trials registration number
The Chinese Clinical Trial Registry, NO. ChiCTR2300070107 (03/04/2023).
Journal Article
A novel flapless approach versus minimally invasive surgery in periodontal regeneration with enamel matrix derivative proteins: a 24-month randomized controlled clinical trial
by
Mariani, Giulia Maria
,
Ferrarotti, Francesco
,
Romano, Federica
in
Adult
,
Chronic Periodontitis - surgery
,
Dental Enamel Proteins - pharmacology
2017
Objectives
This investigation was designed to compare the effectiveness of enamel matrix derivative (EMD) proteins in combination with flapless or flap procedure in periodontal regeneration of deep intrabony defects.
Materials and methods
Thirty chronic periodontitis patients who had at least one residual periodontal defect with an intrabony component of ≥3 mm were consecutively enrolled. Defects were randomly assigned to test or control treatments which both consisted of the use of EMD to reach periodontal regeneration. Test sites (
n
= 15) were treated according to a novel flapless approach, whereas control sites (
n
= 15) by means of minimally invasive surgery (MIST). Clinical and radiographic parameters were recorded at baseline, 12 and 24 months post-operatively.
Results
Both therapeutic modalities yielded similar probing depth (PD) reduction and clinical attachment level (CAL) gain at 24 months. In flapless-treated sites, a mean PD reduction of 3.6 ± 1.0 mm and a CAL gain of 3.2 ± 1.1 mm were observed. In the MIST group, they were 3.7 ± 0.6 and 3.6 ± 0.9 mm. The operative chair time was twice as long in the MIST compared to the flapless group, whereas comparable patient-oriented outcomes were observed.
Conclusion
The flapless procedure may be successfully applied in the regenerative treatment of deep intrabony defects reaching clinical outcomes comparable with those of minimally invasive surgical approaches and may present important advantages in terms of reduction of operative chair time.
Clinical relevance
The use of EMD as an adjunct to non-surgical periodontal treatment may be considered a suitable option to treat defects mainly in the anterior sextants.
Journal Article
Early postoperative evaluation of an open-source digital workflow for designing custom-made zirconia membranes in maxillary guided bone regeneration
by
Sakr, Muhammad Ibrahim
,
Mansour, Noha Ahmed
,
Tawfik, Mohamed Abdel-Monem
in
Accuracy
,
Adult
,
Alveolar bone
2025
Background
Computer-guided surgery has played a crucial role in planning alveolar ridge augmentation. In the last decade, various software programs have been used in computer-guided fabricated nonresorbable membranes, including zirconia membranes, for guided bone regeneration. However, most of these software programs are not free of charge.
Objectives
This study aimed to evaluate clinically and radiographically the accuracy of an open-source digital workflow for designing custom-made zirconia membranes for maxillary guided bone regeneration.
Materials and methods
Twelve custom-made zirconia membranes were designed for 12 patients with maxillary alveolar defects via the integration of two free open-source software programs (Blue Sky Plan
®
and Autodesk Meshmixer
®
) via a preoperative cone beam computed tomography scan. All patients underwent maxillary alveolar bone augmentation via the designed membranes and particulate mixtures of 1:1 autogenous and xenogenic bone grafts. The membranes were evaluated intraoperatively and radiographically via an immediate postoperative cone beam computed tomography scan, and the collected data were statistically analysed.
Results
All the membranes had accurate intraoperative fits, and there were no significant differences between the virtual and milled (actual) membranes in either the volumetric analysis or the linear horizontal and vertical measurements; the P values were (0.628, 0.226 and 0.239), respectively. The designing time was significantly reduced from 4 h for the first case to 22 min for the final case, while the (mean ± standard deviation) milling time was 28 min ± 11 min, and the (mean ± standard deviation) time of the whole digital workflow including membrane sterilization was 5 h and 20 min ± 1 h and 15 min.
Conclusion
Zirconia membranes can be designed with free open-source software with outstanding clinical fit and promising radiographic results. Further research should be performed with larger sample sizes and other rigid Guided Bone Regeneration membrane materials.
Trial registration number
NCT06227455.
Trial first posted date
26/1/2024 (Retrospectively registered).
Journal Article
Periodontal Tissue Regeneration Using Fibroblast Growth Factor -2: Randomized Controlled Phase II Clinical Trial
2008
The options for medical use of signaling molecules as stimulators of tissue regeneration are currently limited. Preclinical evidence suggests that fibroblast growth factor (FGF)-2 can promote periodontal regeneration. This study aimed to clarify the activity of FGF-2 in stimulating regeneration of periodontal tissue lost by periodontitis and to evaluate the safety of such stimulation.
We used recombinant human FGF-2 with 3% hydroxypropylcellulose (HPC) as vehicle and conducted a randomized double-blinded controlled trial involving 13 facilities. Subjects comprised 74 patients displaying a 2- or 3-walled vertical bone defect as measured > or = 3 mm apical to the bone crest. Patients were randomly assigned to 4 groups: Group P, given HPC with no FGF-2; Group L, given HPC containing 0.03% FGF-2; Group M, given HPC containing 0.1% FGF-2; and Group H, given HPC containing 0.3% FGF-2. Each patient underwent flap operation during which we administered 200 microL of the appropriate investigational drug to the bone defect. Before and for 36 weeks following administration, patients underwent periodontal tissue inspections and standardized radiography of the region under investigation. As a result, a significant difference (p = 0.021) in rate of increase in alveolar bone height was identified between Group P (23.92%) and Group H (58.62%) at 36 weeks. The linear increase in alveolar bone height at 36 weeks in Group P and H was 0.95 mm and 1.85 mm, respectively (p = 0.132). No serious adverse events attributable to the investigational drug were identified.
Although no statistically significant differences were noted for gains in clinical attachment level and alveolar bone gain for FGF-2 groups versus Group P, the significant difference in rate of increase in alveolar bone height (p = 0.021) between Groups P and H at 36 weeks suggests that some efficacy could be expected from FGF-2 in stimulating regeneration of periodontal tissue in patients with periodontitis.
ClinicalTrials.gov NCT00514657.
Journal Article
Linear bone gain and healing complication rate comparative outcomes following ridge augmentation with custom 3D printed titanium mesh vs Ti-reinforced dPTFE. A randomized clinical trial
by
Chenchev, Ivan
,
Giragosyan, Krikor
,
Ivanova, Vasilena
in
Clinical trials
,
Edentulous
,
Medical device industry
2024
Aim : The aim of this randomized clinical trial was to compare the qualitative (linear alveolar ridge changes) and quantitative (healing complications) outcomes after guided bone regeneration (GBR) using a custom-made 3D printed titanium mesh versus titanium reinforced dense PTFE membrane for vertical and horizontal augmentation of deficient alveolar ridges. Materials and methods : Forty patients (40 defect sites) were included in the analysis. The patients were divided into two groups – a test group that received custom made Ti mesh and a control group which received a titanium reinforced dense polytetrafluoroethylene membrane. This case series documented consecutive patients treated with vertical bone augmentation to facilitate the future placement of dental implants. The procedure was performed using xenograft and autograft in a ratio of 1:1. Baseline vertical and horizontal deficiencies, acquired bone height and width as well as absolute bone gain (height and width) were recorded radiographically; postoperative complication rate was recorded clinically. Results : The absolute bone height acquired for the test group was 3.65±1.73 mm, and for the control group - 4.24±2.19 mm; the absolute bone width acquired for the test group was 2.48±1.03 mm and for the control group - 2.60±0.82 mm. Postop complication rate was 33.3% for the test group and 38.9% for the control group. Conclusion : The use of a custom-made 3D printed titanium mesh for needs of vertical and horizontal guided bone regeneration showed results comparable to those of – Ti d-PTFE both in terms of height and width gain and complication rate.
Journal Article
Comparative Evaluation of Autologous Sticky Bone, Platelet-Rich Fibrin, and Octacalcium Phosphate–Coated Deproteinized Bovine Bone Material for the Regeneration of Human Periodontal Infrabony Defects: Protocol for a Randomized Controlled Clinical Trial
by
Kotecha, Sakshi Vishal
,
Jaiswal, Priyanka
,
Bhagat, Shweta
in
Adult
,
Alveolar Bone Loss
,
Animals
2025
The term periodontium encompasses the supporting structures around a tooth, including gingival tissue, alveolar bone, cementum, and periodontal ligament. Periodontal disorders are highly prevalent, affecting approximately 95% of the Indian population. Restoring the missing attachment apparatus is the main goal of regenerative therapy in cases of periodontal disease. The reproduction or rebuilding of damaged or lost periodontal tissue to restore the structure and functionality of the periodontium is known as regeneration. This study investigates the effectiveness of autologous sticky bone (ASB), autologous platelet-rich fibrin (PRF), and octacalcium phosphate-coated deproteinized bovine bone material (OCP-DBBM). These materials are being evaluated for their potential to enhance bone regeneration in infrabony defects, which are a significant concern in periodontal therapy. Effective bone regeneration is critical for the successful treatment of periodontal defects, as it can lead to improved clinical outcomes, including better attachment levels and reduced probing depths. This study aims to provide insights into the most effective methods for achieving these goals.
We aim to assess the efficacy of ASB and autologous PRF in conjunction with OCP-DBBM in infrabony defects at 6 months after surgery with regard to radiographic bone fill, reduction in probing pocket depth, and increase in clinical attachment level.
This randomized controlled clinical trial will be performed on 20 defects in patients diagnosed with stage 2 and 3 grade B periodontitis. It will be a parallel-designed study where group 1 (n=10) will be treated with ASB and group 2 (n=10) will be treated with autologous PRF and OCP-DBBM. One sitting will be required to perform the treatment, and a follow-up checkup will be done at 6 months.
Recruitment procedures started in June 2025. All data are anticipated to be collected by February 2026. Full trial results are anticipated to be analyzed and submitted for publication by March 2026. The study's anticipated end date is March 2026.
Both treatment approaches are expected to lead to notable gains in periodontal health and bone regeneration. The primary outcome, radiographic bone fill, and the secondary outcomes, clinical attachment level gain and probing pocket depth reduction, are critical indicators of treatment success.
Clinical Trials Registry-India CTRI/2024/06/069603; https://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=MTAzODk0&Enc=&userName=.
PRR1-10.2196/69666.
Journal Article
Changes in soft tissue dimensions following horizontal guided bone regeneration with a split-thickness flap design – evaluation of 8 cases with a digital method
by
Solyom, Eleonora
,
Bartha, Ferenc
,
Palkovics, Daniel
in
Adult
,
Aged
,
Alveolar Ridge Augmentation - methods
2024
Background
Peri-implant soft tissue corrections are often indicated following alveolar ridge augmentation, due to the distortion of the keratinized mucosa at the area of augmentation. The objective of the current study was to evaluate the dimensional soft tissue changes following horizontal guided bone regeneration (GBR) utilizing 3D digital data.
Methods
8 mandibular surgical sites with horizontal alveolar ridge deficiencies were treated utilizing a resorbable collagen membrane and a split-thickness flap design. Baseline and 6-month follow-up cone-beam computed tomography (CBCT) scans were reconstructed as 3D virtual models and were superimposed with the corresponding intraoral scan. Linear changes of supracrestal vertical- horizontal soft tissue alterations were measured in relation to the alveolar crest at the mesial- middle- and distal aspect of the surgical area. Soft tissue dimensions were measured at baseline and at 6-month follow-up.
Results
Preoperative supracrestal soft tissue height measured midcrestally averaged at 2.37 mm ± 0.68 mm, 2.37 mm ± 0.71 mm and 2.64 mm ± 0.87 mm at the mesial-, middle- and distal planes. Whereas postoperative supracrestal soft tissue height was measured at 2.62 mm ± 0.72 mm, 2.67 mm ± 0.67 mm and 3.69 mm ± 1.02 mm at the mesial, middle and distal planes, respectively. Supracrestal soft tissue width changed from 2.14 mm ± 0.72 mm to 2.47 mm ± 0.46 mm at the mesial, from 1.72 mm ± 0.44 mm to 2.07 mm ± 0.67 mm and from 2.15 mm ± 0.36 mm to 2.36 mm ± 0.59 mm at the mesial, middle and distal planes, respectively. Additionally the buccal horizontal displacement of supracrestal soft tissues could be observed.
Conclusions
The current study did not report significant supracrestal soft tissue reduction following horizontal GBR with a split-thickness flap. Even though there was a slight increase in both vertical and horizontal dimensions, differences are clinically negligible.
Trail registration
The trail was approved by the U.S. National Library of Medicine (
www.clinicaltrials.gov
); trial registration number: NCT05538715; registration date: 09/09/2022.
Journal Article
Minimally invasive non-surgical vs. surgical approach for periodontal intrabony defects: a randomised controlled trial
2019
Background
Periodontal intrabony defects are usually treated surgically with the aim of increasing attachment and bone levels and reducing risk of progression. However, recent studies have suggested that a minimally invasive non-surgical therapy (MINST) leads to considerable clinical and radiographic defect depth reductions in intrabony defects. The aim of this study is to compare the efficacy of a modified MINST approach with a surgical approach (modified minimally invasive surgical therapy, M-MIST) for the treatment of intrabony defects.
Methods
This is a parallel-group, single-centre, examiner-blind non-inferiority randomised controlled trial with a sample size of 66 patients. Inclusion criteria are age 25–70, diagnosis of periodontitis stage III or IV (grades A to C), presence of ≥ 1 ‘intrabony defect’ with probing pocket depth (PPD) > 5 mm and intrabony defect depth ≥ 3 mm. Smokers and patients who received previous periodontal treatment to the study site within the last 12 months will be excluded. Patients will be randomly assigned to either the modified MINST or the M-MIST protocol and will be assessed up to 15 months following initial therapy. The primary outcome of the study is radiographic intrabony defect depth change at 15 months follow-up. Secondary outcomes are PPD and clinical attachment level change, inflammatory markers and growth factors in gingival crevicular fluid, bacterial detection, gingival inflammation and healing (as measured by geometric thermal camera imaging in a subset of 10 test and 10 control patients) and patient-reported outcomes.
Discussion
This study will produce evidence about the clinical efficacy and potential applicability of a modified MINST protocol for the treatment of periodontal intrabony defects, as a less invasive alternative to the use of surgical procedures.
Trial registration
ClinicalTrials.gov,
NCT03797807
. Registered on 9 January 2019.
Journal Article