| CTRI Number |
CTRI/2024/06/068401 [Registered on: 05/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different surgeries to fix gum problems caused by deep pockets around teeth. One way involves making small cuts in the gum, while the other involves lifting the gum away. Also a special membrane made from platelets to help with healing is used. |
|
Scientific Title of Study
|
Comparative evaluation of Non-Incised Papilla Surgical Approach technique (NIPSA) and Open Flap Debridement (OFD) for the treatment of intrabony defect using Platelet Rich Fibrin (PRF) membrane- A Randomised Controlled 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 Prasad Nadig |
| Designation |
Professor of Periodontology |
| Affiliation |
KM Shah Dental College Waghodia Vadodra-391760 |
| Address |
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Dept of Periodontology Room No 7 At and Po Pipariya Ta Waghodia Dist Vadodra 391760 Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
8469779161 |
| Fax |
|
| Email |
drprasadnadig@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Nadig |
| Designation |
Professor of Periodontology |
| Affiliation |
KM Shah Dental College Waghodia Vadodra-391760 |
| Address |
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Dept of Periodontology Room No 7 At and Po Pipariya Ta Waghodia Dist Vadodra 391760 Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
8469779161 |
| Fax |
|
| Email |
drprasadnadig@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prasad Nadig |
| Designation |
Professor of Periodontology |
| Affiliation |
KM Shah Dental College Waghodia Vadodra-391760 |
| Address |
Sumandeep Vidyapeeth Campus KM Shah Dental College And Hospital Dept of Periodontology Room No 7 At and Po Pipariya Ta Waghodia Dist Vadodra 391760 Gujarat India
Vadodara
GUJARAT
391760
India |
| Phone |
8469779161 |
| Fax |
|
| Email |
drprasadnadig@gmail.com |
|
|
Source of Monetary or Material Support
|
| K M Shah Dental College and Hospital, Pipariya, Waghodia-391760, Vadodara, Gujarat India. |
|
|
Primary Sponsor
|
| Name |
Kajol Bhavsar |
| Address |
Vama hostel, Sumandeep Vidyapeeth University, Waghodia , Pipariya, Vadodra-391760, Gujarat(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 Kajol Bhavsar |
K M Shah Dental College and Hospital |
Department of Periodontology, Room No 7, Second Floor
Vadodara
GUJARAT |
9512662998
kajolbhavsar603@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SUMANDEEP VIDYAPEETH INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stage II or Stage III Grade A Periodontitis |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Non Incised Papilla Surgical Approach with PRF |
The non-incised papilla surgical approach NIPSA is a technique that accesses the periodontal defect from its apical aspect and was developed with the aim of achieving clinical improvements compared with marginal access techniques NIPSA allows the structure of the interproximal tissue to be maintained without affecting or detaching the marginal tissues which remain firmly inserted in the adjacent areas |
| Comparator Agent |
Open Flap Debridement with PRF |
Full thickness Mucoperiosteal flap will be reflected and PRF will be used |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Age between 25 to 60 years
2.Systemically healthy patients
3.Subjects with minimum 20 natural teeth remaining
4.Subjects having Stage II or Stage III Grade A Periodontitis
5.Radiographic evidence of Intrabony defect |
|
| ExclusionCriteria |
| Details |
1.Subjects consuming any form of tobacco.
2.Pregnant and lactating women.
3. Having symptoms of acute illness or pulpal pain at the time of the study
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pocket probing depth, Clinical attachment level, Gingival Index, Plaque Index, Recession, Papillary fill |
Pocket probing depth, Clinical attachment level, Gingival Index, Plaque Index, Recession, Papillary fill |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Radiographic Bone fill |
Radiographic Bone fill, Time point: 6 months |
|
|
Target Sample Size
|
Total Sample Size="58"
Sample Size from India="58"
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 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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="6"
Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 randomized, double blind, parallel group study evaluating the Non Incised Papilla Surgical Approach technique and Open Flap Debridement for the treatment of intrabony defect by using Platelet Rich Fibrin . The following Clinical parameters that is Gingival Index, Plaque Index, Clinical Attachment Level, Pocket Probing Depth, Recession and Papillary fill are taken at baseline and 6 months and Radiographic parameters that is Radiographic bone fill is taken at baseline and 6 months. The total sample size is 58 |