| CTRI Number |
CTRI/2026/04/108660 [Registered on: 20/04/2026] Trial Registered Prospectively |
| Last Modified On: |
18/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of Conventional and Advanced Surgical Techniques in the Treatment of Gum Disease |
|
Scientific Title of Study
|
A comparative clinical and radiographical evaluation of conventional and microsurgical open flap debridement in the treatment of chronic periodontitis – A split-mouth 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 |
Akul Bhatt |
| Designation |
Post Graduate student |
| Affiliation |
Room no 5 department of periodontology, College of Dental Science and Hospital, Amargadh |
| Address |
Room no 5 department of periodontology, College of Dental Science and Hospital, Amargadh
college of dental science, amargadh
Bhavnagar
GUJARAT
363310
India |
| Phone |
7621080158 |
| Fax |
|
| Email |
akulbhatt03@gmaill.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chandrashekar B |
| Designation |
PG guide and Professor |
| Affiliation |
College of Dental Science and hospital |
| Address |
room no 5 department of periodontology college of dental science, Amargadh, Sihor, Bhavnagar, Gujarat 364210
College of Dental Science and hospital,amargadh
Bhavnagar
GUJARAT
364210
India |
| Phone |
7093826756 |
| Fax |
|
| Email |
drchanduperio@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chandrashekar B |
| Designation |
PG guide and Professor |
| Affiliation |
room no 5 department of periodontologyCollege of Dental Science and hospital |
| Address |
room no 5 department of periodontology college of dental science and hospital, Amargadh, Sihor, Bhavnagar, Gujarat 364210
college of dental science and hospital ,amargadh.
Bhavnagar
GUJARAT
364210
India |
| Phone |
7093826756 |
| Fax |
|
| Email |
drchanduperio@yahoo.com |
|
|
Source of Monetary or Material Support
|
| College of Dental Science and hospital |
|
|
Primary Sponsor
|
| Name |
College of Dental Science and hospital |
| Address |
College of Dental Science and hospital, K.J Mehta trust, Amrgadh, Sihor, Bhavnagar 364210 |
| Type of Sponsor |
Private medical college |
|
|
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 Akul Bhatt |
College of dental science amargadh |
room no 5 Department of Periodontology
Bhavnagar
GUJARAT |
7621080158
akulbhatt03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic periodontitis with horizontal bone loss |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group 1 |
on one quadrant Kirkland with conventional flap surgery |
| Intervention |
intervention |
on other quadrant Kirkland flap with microsurgical flap surgery |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Pocket probing depth 4 to 7 mm
Relative attachment level 1 to 4 mm
Radiographic evidence of horizontal bone loss.
Patients who demonstrated acceptable oral hygiene prior to surgical therapy.
Patients willing to participate in
study.
|
|
| ExclusionCriteria |
| Details |
•Patient with history of aggressive periodontitis.
•Vertical bone defects/ furcation defects requiring periodontal regeneration.
•History of known systemic diseases like hypertension, diabetes, HIV, Hepatitis, bone metabolic disorders, radiation therapy, immunosuppressive therapy, cancer, blood disorders.
•Medications known to affect the outcomes of periodontal therapy.
•Patients who had undergone any periodontal therapy in the preceding 6 months.
•Pregnant or lactating women.
•Use of tobacco in any form.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare probing pocket depth reduction following microsurgical and conventional periodontal flap surgery.
To assess and compare relative attachment level gain between the two surgical techniques.
|
1 week, 4 weeks, 3 months, 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate and compare the changes in gingival recession at baseline and at postoperative follow-up periods following microsurgical and convention periodontal flap surgery.
To compare the gingival inflammation using gingival index following both procedures.
To assess plaque control using plaque index in both groups.
To evaluate postoperative wound healing using Landry healing index.
To compare pain with VAS scale and patient comfort using patient satisfactory score between microsurgical and conventional flap surgery. |
1 week, 4 weeks, 3 months, 6 months |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 |
|
Date of First Enrollment (India)
|
01/08/2026 |
| 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="2"
Months="0"
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 a split-mouth randomized controlled trial comparing conventional open flap debridement and microsurgical open flap debridement in patients with chronic periodontitis and horizontal bone loss. Sixteen patients (32 sites) will undergo both techniques in different quadrants. Clinical, radiographic, and patient-centered parameters such as probing pocket depth, relative attachment level, gingival and plaque indices, wound healing, pain perception, and patient satisfaction score will be evaluated up to 6 months. The study aims to determine whether microsurgical flap surgery provides superior healing and patient comfort compared to the conventional approach. |