| CTRI Number |
CTRI/2024/07/069848 [Registered on: 03/07/2024] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare and evaluate the effectiveness of Alloplastic Bone Graft with and without advanced human blood clot in the treatment of bone defects in patients with chronic gum disease. |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic Evaluation of Efficacy of G-BONE™ (Hydroxyapatite and Beta Tricalcium Phosphate) Versus G-BONE™ (Hydroxyapatite and Beta Tricalcium Phosphate) with Advanced Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients – A Randomized Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Aiswarya Raveendran K |
| Designation |
First year Postgraduate MDS, Department of Periodontics |
| Affiliation |
Nair hospital Dental College, Mumbai |
| Address |
Room no.201,Department of Periodontics Nair Hospital Dental College,Mumbai Maharashtra, 400008 India
Mumbai
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9497470846 |
| Fax |
|
| Email |
aiswaryaraveendran020@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Nair hospital Dental College,Mumbai |
| Address |
Room no 201, Department of Periodontics, Nair Hospital Dental College,Mumbai,Maharashtra, 400008 India
Mumbai
MAHARASHTRA
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mala Dixit Baburaj |
| Designation |
Professor and Head of the Department |
| Affiliation |
Nair hospital Dental College,Mumbai |
| Address |
Room no 201, Department of Periodontics, Nair Hospital Dental College,Mumbai,Maharashtra, 400008 India
Mumbai
MAHARASHTRA
400008
India |
| Phone |
9223340938 |
| Fax |
|
| Email |
maladixit25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Aiswarya Raveendran K, Room no. 201, Nair Hospital Dental College, Mumbai, 400008, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Aiswarya Raveendran K |
| Address |
Room no. 201, Nair Hospital Dental College, Mumbai, 400008, Maharashtra, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Aiswarya Raveendran K |
Nair Hospital Dental College,Mumbai |
Room 201, department of Periodontics, second floor, Nair Hospital Dental College, Mumbai Central 400008, Maharashtra
Mumbai
MAHARASHTRA |
9497470846
aiswaryaraveendran020@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Nair Hospital Dental College |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hydroxyapatite and Beta Tricalcium Phosphate alloplastic graft |
Hydroxyapatite and Beta Tricalcium Phosphate(G-BONEâ„¢ ) alloplastic graft.
Total duration is 18 months |
| Intervention |
Hydroxyapatite and Beta Tricalcium Phosphate alloplatic graft with Advanced Platelet Rich Fibrin |
Hydroxyapatite and Beta Tricalcium Phosphate(G-BONEâ„¢ )alloplastic graft with Advanced Platelet Rich Fibrin.
Total duration is 18 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients with chronic periodontitis
2) Patients who are non smokers or do not consume tobacco in any other form
3) Patients in good systemic health with no contraindication to periodontal surgery
4) Patients having pocket depths greater than 5mm, intraosseous defects greater than 3mm and with radiographic evidence of vertical or angular bone loss in the affected sites |
|
| ExclusionCriteria |
| Details |
1) One-walled osseous defects.
2) Patients suffering from any systemic diseases or with a compromised immune system.
3) Patients who had received any type of periodontal therapy for the past 6 months.
4) Patients taking immunosuppressant drugs like corticosteroids.
5) Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study.
6) Patients showing unacceptable oral hygiene compliance during / after Phase I periodontal therapy.
7) Patients taking any drug known to cause gingival enlargement.
8) Pregnant and/or lactating mothers.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Plaque Index (P.I) Tureskey-Gilmore-Glickman Modification of Quigley Hein)
2.Gingival Index (G.I) (Loe and Sillness,1963) 3.Probing Pocket Depth (PPD)
4.Clinical Attachment Level (CAL) |
1) At Baseline 2) After 1 month 3) After 3 month 4) After 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The radiographic bone fill will be evaluated using Intraoral Periapical Radiographs of the surgical site. |
Baseline- at baseline,immediately after the surgery and 6 months post surgery |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
03/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Introduction Periodontal disease is a chronic inflammatory condition that forms pathological pockets around affected teeth, leading to the loss of connective tissue and alveolar bone. Exposure to dental plaque and biofilms results in bacterial buildup, often starting as gingivitis and progressing to periodontitis. Treatment aims to restore damaged tissues, with periodontal regeneration involving the growth of new alveolar bone, cementum, and periodontal ligaments using various bone grafts like autografts, allografts, xenografts, and synthetic grafts. Calcium phosphate bone grafts, such as hydroxyapatite (HA) and tricalcium phosphate (TCP), meet the requirements for synthetic biomaterials due to their nontoxic and stable nature. PRF, introduced in 2001, and its advanced form A-PRF, developed in 2014, have shown significant effectiveness in tissue regeneration, releasing growth factors like PDGF, TGF-β and VEGF. A-PRF, with higher leukocyte and platelet concentrations, enhances fibroblast migration and collagen production, offering sustained cytokine release. When combined with bone grafts, A-PRF promotes greater bone fill and attachment gain. The study aims to compare the bone fill in human intrabony defects using G-BONE™ (a combination of hydroxyapatite and beta-tricalcium phosphate) with Advanced platelet rich fibrin, focusing on patients with chronic periodontitis to evaluate the effectiveness of these treatments in bone regeneration.
Aims & Objectives To evaluate and compare clinically and radiographically efficacy of G-BONEâ„¢ (Hydroxyapatite and Beta Tricalcium Phosphate) Versus G-BONEâ„¢ (Hydroxyapatite and Beta Tricalcium Phosphate) with Advanced Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients.
Materials and Methods Fourty two intrabony defects were randomly two different groups and were treated with group A G-BONE™ (Hydroxyapatite and Beta Tricalcium Phosphate) and group B G-BONE™ (Hydroxyapatite and Beta Tricalcium Phosphate) with Advanced Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients Clinical parameters such as plaque index (PI),gingival index (GI), pocket probing depth (PPD), clinical attachment level (CAL) were assessed at baseline 1 month, 3 month and 6 month Postoperatively y; radiographic parameter such as percentage in bone fill (%BF) were calculated by using the computerized image analysis software. Data collected will be compiled on to a MS Office excel worksheet & will be subjected to statistical analysis using an appropriate package like SPSS software. Normality of numerical data will be checked using Shapiro – Wilk test or Kolmogorov-Smirnov test. Depending on the normality of data, statistical tests will be determined. For a numerical continuous data following a normal distribution, inter group comparison (2 groups) will be done using t test, else a non-parametric substitute like Mann Whitney U test will be used. Descriptive statistics like frequency (n) & percentage (%) of categorical data, mean & Standard deviation of numerical data in each group will be depicted & may be compared using chi square test.Intra group comparisons for a numerical continuous data following a normal distribution will be done using paired t test (for 2 observations) or repeated measures ANOVA for >2 observations, else a non-parametric substitute like Wilcoxon signed rank test (for 2 observations) or Friedman’s test for >2 observations will be used. Keeping alpha error at 5% and Beta error at 20%, power at 80%, p<0.05 will be considered statistically significant.
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