| CTRI Number |
CTRI/2026/02/103082 [Registered on: 05/02/2026] Trial Registered Prospectively |
| Last Modified On: |
05/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Laser Therapy and MMP-9 Levels in Healing After Gum Surgery in Patients with Long-Term Gum Disease: A Study Using Two Sides of the Mouth |
|
Scientific Title of Study
|
COMPARISON OF LOW-LEVEL LASER THERAPY AND MMP-9 LEVELS ON
WOUND HEALING FOLLOWING OPEN FLAP DEBRIDEMENT IN CHRONIC
PERIODONTITIS PATIENTS: A SPLIT-MOUTH RANDOMIZED CONTROL
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 BHUMIKA RAO S |
| Designation |
Post- graduate student |
| Affiliation |
Bapiji Dental College and Hospital |
| Address |
Bapuji Dental college and Hospital
MCCB Block
Davangere 577004
Bapuji Dental college and Hospital
Room no 5
Department of Periodontics
MCCB Block
Davangere 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
8746818249 |
| Fax |
|
| Email |
drbhumikaraos@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Daya S |
| Designation |
Reader |
| Affiliation |
Bapiji Dental College and Hospital |
| Address |
Bapuji Dental college and Hospital
MCCB Block
Davangere 577004
Bapuji Dental college and Hospital
Room no 5
Department of Periodontics
MCCB Block
Davangere 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
8746818249 |
| Fax |
|
| Email |
dayas55@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Daya S |
| Designation |
Reader |
| Affiliation |
Bapiji Dental College and Hospital |
| Address |
Bapuji Dental college and Hospital
MCCB Block
Davangere 577004
Bapuji Dental college and Hospital
Room no 5
Department of Periodontics
MCCB Block
Davangere 577004
Davanagere
KARNATAKA
577004
India |
| Phone |
8746818249 |
| Fax |
|
| Email |
dayas55@gmail.com |
|
|
Source of Monetary or Material Support
|
| BAPUJI DENTAL COLLEGE AND HOSPITAL
Davangere
Karnataka
India
577004 |
|
|
Primary Sponsor
|
| Name |
Dr Bhumika Rao S |
| Address |
DEPARTMENT OF PERIODONTICS
BAPUJI DENTAL COLLEGE AND HOSPITAL
Davangere
India
577004
MCC B BLOCK
DAVANGERE |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrBHUMIKA RAO S |
BAPUJI DENTAL COLLEGE AND HOSPITAL |
Bapuji Dental college and Hospital
Room no 5
Department of Periodontics
MCCB Block
Davangere
Davangere 577004
Bapuji Dental college and Hospital
MCCB Block
Davangere 577004
Davanagere
KARNATAKA |
08746818249
drbhumikaraos@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD BAPUJI DENTAL COLLEGE AND HOSPITAL DAVANGERE |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Chronic Periodontitis patients |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
MMP 9 levels and Low level laser therapy |
Collection of GCF:12
Samples of GCF will be obtained with a help of micropipettes at baseline and after 3 months post-operatively. The samples contaminated by saliva or blood should be discarded. The procedure was carried out carefully without any mechanical trauma. The capillary tubes are inserted close to the entrance of the gingival crevice i.e., extracrevicularly. GCF from the crevice migrates into the tube by capillary action. The samples from the selected site should be subsequently stored and quantification of the MMP-9 is done using enzyme-linked immunosorbent assay.
The LLLT protocol:
In the test group, the periodontal locations should be exposed to LLLT using a diode laser with a wavelength of 660nm (SIRO Laser Blue, Sirona) with 25 mW power output in the continuous wave mode. Sweeping movements will be made from mesiodistally (horizontally) and in apico-coronal direction (vertically). Regardless of the treatment group, the patients and the operator will be advised to wear safety glasses in all sessions. The test group will undergo laser bio-stimulation for 120 seconds on the baseline, third, and seventh days following flap surgery in non-contact mode. The control group will receive placebo laser therapy without pushing the start button.
|
| Intervention |
Open flap debridement |
The surgical area is likely to be anesthetized using local anaesthetic (2% lignocaine with adrenaline 1:80,000).To reflect a full-thickness mucoperiosteal flap, intra-crevicular incisions using Bard-Parker(B.P) no.15C surgical blades will be performed on the buccal and lingual surfaces. To support primary wound closure and retain the complete interdental papillae, the incisions should be made as far interproximal as feasible. Full-thickness mucoperiosteal flaps should be elevated up to the crest of the alveolar bone and a thorough planing of roots should be done. Gracey curettes (Hu-Friedy) should be used to remove all of the granulation tissues. Furthermore, the granulation tissues from the periodontal flaps interior should also be eliminated. Subsequently, interrupted sutures (3-0) would be used to suture the flap.
|
|
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Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Patients in the age group of 25 to 60 years
• Patients should be systematically healthy
• Chronic Periodontitis patients, probing depth greater than or equal to 5mm
• Patients who have not undergone periodontal therapy in the past 6 months
|
|
| ExclusionCriteria |
| Details |
• Patients who are smokers, alcoholics or tobacco chewers.
• Patients not willing to participate in the study or not available for follow up.
• Pregnant and lactating women
• Intake of drugs that affect on periodontal disease clinical symptoms (eg, long-term steroid use or calcium channel blocker)
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|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Wound Healing and MMP 9 levels |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Clinical Indices |
Baseline and 3 months |
|
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Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
16/02/2026 |
| 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="0"
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 - NO
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Brief Summary
|
Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic plaque biofilms and characterized by progressive destruction of the tooth-supporting apparatus.Its main characteristics include gingival bleeding, periodontal pocketing, radiographically measured alveolar bone loss, and clinical attachment loss (CAL), which indicate a loss of periodontal tissue support. Treatment for periodontitis should be administered gradually, with the first part emphasizing on enhancing the patient’s oral hygiene practices and managing risk factors, and the second part focusing on expert removal of calculus and supragingival biofilm, either with or without adjunctive therapies. The third phase of treatment is centered on either regenerating or resecting lesions that complicate the management of periodontitis by access flap surgery, or on treating sites that did not respond well to the second phase of therapy to gain access to deep pocket sites for successful debridement as well as to enable effective self-plaque control. However, a several of adverse effects after periodontal surgery including discomfort, edema, and inflammation.Additionally, Low Level Laser Therapy exhibits anti-inflammatory properties and promotes analgesic effects on acute and chronic pain, restoration of microcapillary circulation, normalization of vascular wall permeability, and reduction of edema.MMPs can be considered a risk factor for periodontal disease, and measurements of MMP-9 levels may be useful as markers for early detection of periodontitis and as a tool to assess prognostic follow-ups
On thorough literature search we didn’t come across any study which describes the effect of LLLT (Using 660nm) in wound healing and levels of MMP-9 following open flap debridement in chronic periodontitis patients.Thus, this study aims to assess the effectiveness of LLLT done in conjunction with open flap debridement on wound healing, and in MMP-9 levels in chronic periodontitis patients
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