| CTRI Number |
CTRI/2025/02/080957 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Screening
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparative study of PRF and bone graft and gum surgery with bone drilling for the regrowth of bone in bone loss patients |
|
Scientific Title of Study
|
Comparative evaluation of open flap debridement with intramarrow penetration with and without PRF and Bone graft in the treatment of horizontal bone defect- A clinico radiographical study |
| 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 Suchitra B |
| Designation |
Post Graduate student |
| Affiliation |
coorg institute of dental sciences |
| Address |
Room no 4,department of periodontology and implantology, Coorg institute of dental sciences, KK campus, magulla village, virajpet, karnataka-571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7812034749 |
| Fax |
|
| Email |
suchibarath@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Suchitra B |
| Designation |
Post Graduate student |
| Affiliation |
coorg institute of dental sciences |
| Address |
room no 4, department of periodontology and implantology Coorg institute of dental sciences, KK campus, magulla village, virajpet, karnataka-571218
Kodagu
KARNATAKA
571218
India |
| Phone |
7812034749 |
| Fax |
|
| Email |
suchibarath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amit K walvekar |
| Designation |
HOD |
| Affiliation |
Coorg institute of dental sciences |
| Address |
Room no 4, Department of periodontology and implantology,Coorg institute of dental sciences, KK campus, magulla village, virajpet, karnataka-571218
Kodagu
KARNATAKA
571218
India |
| Phone |
9480085687 |
| Fax |
|
| Email |
amitakw@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg institute of dental sciences, Department of Periodontics and Implantology, Kanjithanda kushalappa campus, magulla, virajpet-571218 |
|
|
Primary Sponsor
|
| Name |
Dr Suchitra B |
| Address |
Coorg institute of dental sciences, KK campus, magulla village, virajpet, karnataka-571218 |
| 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 Suchitra |
coorg institute of dental scince |
Room no 4, department of periodontology and implantology, KK campus,maggula village, virajpet, kodagu, karnataka
Kodagu
KARNATAKA |
7812034749
suchibarath@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Review Board, Coorg institute odf Dental science |
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 |
open flap debridement |
open flap debridement and intramarrow penetration will be done |
| Intervention |
PRF membrane |
open flap debridement and intramarrow penetration will be done and then PRF membrane will be placed over the defect area |
| Intervention |
xenograft |
open flap debridement and intramarrow penetration will be done and then xenograft will be placed in the IMP area and PRF membrane will be placed over the site |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are diagnosed with stage II chronic periodontitis with horizontal defects.Patients with periodontal pocket depths ranging from 5 to 6 mm |
|
| ExclusionCriteria |
| Details |
Systemically compromised patients.
Use of antibiotics in the past 6 months
Steroid or inflammatory drugs for 7 days in 3 months
Known allergy to the above mentioned drugs/substance
Smokers and alcoholic
Pregnant and lactating women
Periodontal therapy within 6 months
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of clinical and radiographical parameters in open flap debridement and intramarrow penetration alone and with platelet rich fibrin and bone graft. |
all clinical parameters and radiographic analysis should be done at baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the results of clinical and radiographical parameters in open flap debridement and intramarrow penetration alone and with platelet rich fibrin and bone graft. |
all clinical parameters and radiographic analysis should be done at baseline, 3 months and 6 months and compare their results |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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 1 |
|
Date of First Enrollment (India)
|
25/02/2025 |
| 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="0"
Months="6"
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
|
This study is designed to be a clinical radiographico study where 18 patients of both the gender with Stage II periodontitis satisfying all the inclusion criteria will be enrolled for the studyThe total sample size calculated is 18 patients. This will be a clinico radiographic study where three sites will be taken. The preoperative protocol comprises of a full mouth scaling and root planing (SRP) treatment, succeeded by meticulous advice regarding oral hygiene protocols. At the 4-week mark, the patients will be recalled for evaluation of persisting pockets followed by flap surgery treatment. Single blinded examiner will perform the clinical examination at baseline, 3 months, and 6 months. After the evaluation of plaque index (PI), gingival index(GI),scores, Periodontal probing depth (PPD),clinical attachment level (CAL) and CBCT radiographical examination, The selected quadrants will be further randomized into Group A, B, and C.The assessment will be carried out on three groups namely: Group A- open flap debridement with intramarrow penetration alone Group B- open flap debridement and intramarrow penetration with PRF Group C-open flap debridement and intramarrow penetration with PRF and bone graft |