| CTRI Number |
CTRI/2025/05/086574 [Registered on: 08/05/2025] Trial Registered Prospectively |
| Last Modified On: |
30/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A clinical trial to study the outcomes of 3 different periodontal surgical techniques- conventional flap, NIPSA and M-MIST in treatment of intraosseous defects in stage III periodontitis. |
|
Scientific Title of Study
|
Efficacy of conventional flap surgery, Non-Incised Papilla Surgical Approach (NIPSA) and Modified Minimally Invasive Surgical Technique (M-MIST) in the management of intraosseous defects in stage III periodontitis- A Randomized Controlled 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 |
TARUN I |
| Designation |
POST GRADUATE |
| Affiliation |
Government dental college, Thiruvananthapuram |
| Address |
Department of Periodontics, Government Dental college, Medical college road, Chalakkuzhi, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8610285809 |
| Fax |
|
| Email |
leotarun2001.perio@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr RASEENA BEEVI N |
| Designation |
PROFESSOR |
| Affiliation |
Government dental college, Thiruvananthapuram |
| Address |
Department of Periodontics, Government Dental college, Medical college road, Chalakkuzhi, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8610285809 |
| Fax |
|
| Email |
raseenakamil@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
TARUN I |
| Designation |
POST GRADUATE |
| Affiliation |
Government dental college, Thiruvananthapuram |
| Address |
Department of Periodontics, Government Dental college, Medical college road, Chalakkuzhi, Thiruvananthapuram, Kerala
Thiruvananthapuram
KERALA
695011
India |
| Phone |
8610285809 |
| Fax |
|
| Email |
leotarun2001.perio@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of periodontics, government dental college,
Medical college road,
Chalakkuzhi, Thiruvananthapuram,
Kerala- 695011,
India. |
|
|
Primary Sponsor
|
| Name |
TARUN I |
| Address |
Department of Periodontics, Government Dental college, Medical college road, Chalakkuzhi, Thiruvananthapuram, Kerala- 695011 |
| 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 TARUN I |
Government dental college |
Department of Periodontics,
Room no. A-203,
Medical college road, Chalakkuzhi,
Thiruvananthapuram,
Kerala-695011
Thiruvananthapuram
KERALA |
8610285809
leotarun2001.perio@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Dental College, Thiruvananthapuram |
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 |
Conventional flap surgey |
The Modified Widman Flap involves 3 incisions. First internal bevel incision is given by a scalloped horizontal incision approximately 1 mm from the buccal gingival margin to remove pocket epithelium. If pockets are less that 2 mm or aesthetics matter, an intracrevicular incision is used. A similar approach is taken palatally, extending between teeth for proper coverage. A second intracrevicular incision reaches the alveolar crest, followed by a third horizontal incision near the bone to elevate full-thickness flaps, exposing minimal bone (Ramfjord et al. 1977). Granulation tissue is removed, roots are scaled except near attachment fibers, and angular defects are curetted. PRF is applied, flaps adjusted, and sutured with interdental sutures.The entire surgical procedure is expected to take approximately 1 hour. |
| Comparator Agent |
Modified Minimally Invasive Surgical Technique. |
M-MIST will be done as described by Cortellini and Tonetti. After local anesthetic administration, Incision is placed. Only one horizontal buccal incision is placed between two teeth at base of papilla 3 mm from tip of interdental papilla. Reflection of full Thickness flap extended apically down to intra-osseous defect is done by means of micro-surgical blade. The granulation tissue is disinserted from the bony walls by mini curettes. The affected root (deep area of the periodontal pocket) was scaled and planed, and calculus eliminated with ultrasonic micro-tips and mini curettes. Once the defect is debrided, PRF is applied. Suturing by internal vertical mattress suturing technique is performed.The entire surgical procedure is expected to take approximately 1 hour.
|
| Comparator Agent |
Non Incised Papilla Surgical Approach. |
NIPSA, as described by Moreno-Rodríguez and Caffesse, involves a single horizontal or oblique apical incision in the mucosa, away from the marginal tissues and aesthetic zone, to access the defect. The incision is extended as needed for proper debridement and clot stabilization. A full-thickness flap is raised while preserving the pre-operative tissue architecture. Granulation tissue is removed using mini curettes and scalpels, ensuring the marginal tissue and residual fibers attached to cementum remain intact. If a lingual defect is present, it is accessed vestibularly. The affected root surface is scaled and planed using ultrasonic micro-tips and curettes. After debridement, PRF is applied, and the incision is closed with a double-layer suture technique—internal horizontal mattress sutures for connective tissue approximation, followed by single interrupted sutures for tension-free closure.The entire surgical procedure is expected to take approximately 1 hour. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age above 20 years with good oral hygiene.
2. Patients who have given written informed consent and are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1. Patients suffering from systemic illness (Diabetes, Hypertension, cardiovascular disorders, patients under steroids/drugs affecting bone metabolism and bleeding or clotting disorders).
2. Smokers.
3. Presence of an orthodontic appliance.
4. Pregnancy or breast feeding.
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing depth |
Baseline, 6 weeks and 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level (CAL). |
Baseline, 6 weeks and 4 months |
| Soft tissue preservation based on Gingival recession (GR) and Location of the Tip of the papillae (TP). |
Baseline,6 weeks and 4 months |
Bleeding on probing (BOP).
|
Baseline, 6 weeks and 4 months |
Plaque index (Silness and Loe index).
|
Baseline 6 weeks and 4 months |
Radiographic bone fill.
|
Baseline and 4 months |
| Patient satisfaction |
6 weeks |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/05/2025 |
| 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="1"
Months="3"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - through journals
- For how long will this data be available start date provided 31-03-2027 and end date provided 31-03-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is a randomized, single blind, parallel group clinical trial evaluating the efficacy of three surgical techniques—Conventional Flap Surgery, Non-Incised Papilla Surgical Approach (NIPSA), and Modified Minimally Invasive Surgical Technique (M-MIST)—in the management of intraosseous defects in 33 patients with Stage III periodontitis. The study will be conducted at the Government Dental College, Thiruvananthapuram, over a period of 15 months. Platelet-rich fibrin (PRF) will be used in all groups as an adjunct to enhance healing. The primary outcome measure is probing depth upto four months. Secondary outcomes include clinical attachment level, soft tissue preservation, radiographic bone fill, bleeding on probing, plaque index, and patient satisfaction assessed at various intervals up to four months. |