| CTRI Number |
CTRI/2024/07/070436 [Registered on: 10/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| 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 Synthetic Bone Graft Material with and without Injectable Human Blood Clot in the Treatment of Bony Defects in Chronic Gum Disease. |
|
Scientific Title of Study
|
Comparative Clinical and Radiographic Evaluation of Efficacy of G-Graft™ (Hydroxyapatite with Collagen) Versus G-Graft™ (Hydroxyapatite with Collagen) with Injectable 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 Priyanka Dalvi |
| Designation |
First Year Post Graduate 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
MAHARASHTRA
400008
India |
| Phone |
7039035186 |
| Fax |
|
| Email |
dalvipriyanka3@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
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. Priyanka Dalvi, Room no.201,Department of Periodontics, Nair Hospital Dental College, Mumbai, Maharashtra, 400008 India |
|
|
Primary Sponsor
|
| Name |
Dr Priyanka Dalvi |
| Address |
Room no 13,A Wing, New Radhika CHS, Central Park, Nalasopara East, Palghar, Maharashtra, 401209 |
| 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 Priyanka Dalvi |
Nair Hospital Dental College, Mumbai |
Room 201, Department
of Periodontics, Second
floor, Nair Hospital
Dental College, Mumbai
Central, 400008,
Maharashtra
Mumbai
MAHARASHTRA |
7039035186
dalvipriyanka3@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Nair Hospital Dental College |
Approved |
|
|
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 with Collagen Alloplastic Graft |
Hydroxyapatite with Collagen Alloplastic Graft (G-Graftâ„¢).
The total duration of is 9 months |
| Intervention |
Hydroxyapatite with Collagen Alloplastic Graft with Injectable Platelet Rich Fibrin (i- PRF) |
Hydroxyapatite with Collagen Alloplastic Graft (G-Graftâ„¢) with Injectable Platelet Rich Fibrin (i- PRF). The total duration is 9 months. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients in the age group of 30 to 60 years.
2) Patients diagnosed with Chronic Periodontitis.
3) Patients who are non smokers or do not consume tobacco in any other form.
4) Patients are in good systemic health with no contraindication to periodontal surgery.
5) Patients having pocket depths greater than 5mm, intraosseous defect greater than 3mm and with radiographic evidence of vertical/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.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
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 Silness, 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 month post-surgery |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
28/11/2024 |
| 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
|
Aims and Objectives:
Comparative Clinical and Radiographic Evaluation of Efficacy of G-Graftâ„¢ (Hydroxyapatite with Collagen) Versus G-Graftâ„¢ (Hydroxyapatite with Collagen) with Injectable Platelet Rich Fibrin in the Treatment of Intrabony Defects in Chronic Periodontitis Patients.
Introduction: Periodontium is a specialized tissue that surrounds and supports the teeth in the jaws. Periodontium may be affected by microorganisms along with the host response, resulting in destruction of the periodontal ligament and alveolar bone. Bone is a dynamic organ that can regenerate and bone grafting is a dynamic phenomenon. Collagen is an osteo inductive material due to its osteoconductive property when it is used in combination with osteoconductive carriers like hydroxyapatite or tricalcium phosphate. The injectable platelet rich fibrin is a newly researched or developed leucocyte-enriched platelet-rich concentrate that has been observed to have better antibacterial action against a variety of periodontal infections, as well as the ability to generate increased fibroblast migration and the production of high levels of growth factor. The purpose of this study is to compare the bone fill of human intrabony defect grafted with G-Graftâ„¢ (Hydroxyapatite with Collagen) and with G-Graftâ„¢ (Hydroxyapatite with Collagen) with Injectable Platelet Rich Fibrin in the treatment of Intrabony Defects in Chronic Periodontitis.
Materials and Method: | The patients selected as per the inclusion and exclusion criteria, will be randomly allotted by a computerized automated randomization method into 2 groups, Group A and Group B, each consisting of 20 patients and treated as follows Group A : Open flap debridement, followed by placement of G-Graftâ„¢ (Hydroxyapatite with Collagen) Group B : Open flap debridement, followed by placement of G-Graftâ„¢ (Hydroxyapatite with Collagen) with Injectable Platelet Rich Fibrin 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; 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. | | |