| CTRI Number |
CTRI/2026/01/101075 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
13/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Laser Treatment Used Along with Gum Surgery, With and Without a Natural Blood-Based Healing Material, on Gum Health and Inflammation Levels in Patients with Chronic Gum Disease. |
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Scientific Title of Study
|
Effect of Low Level Laser Therapy as an adjunct to open flap debridement with and without Albumin platelet rich fibrin on clinical parameters and gingival crevicular fluid interleukin 1beta level in chronic periodontitis patients. A clinico biochemical 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 Anusha K |
| Designation |
3rd year MDS Postgraduate student |
| Affiliation |
Bapuji Dental College and Hospital, Rajiv Gandhi University of Health Sciences |
| Address |
Room no 5, Department of Periodontics, Bapuji Dental College and Hospital, MCC B Block, MCC, Davangere- 577004
Davanagere KARNATAKA 577004 India |
| Phone |
09845432616 |
| Fax |
|
| Email |
anushaanu2628@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Gayathri G V |
| Designation |
Professor and Head |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no 5, Department of Periodontics, Bapuji Dental College and Hospital, MCC B Block, Davangere- 577004
Davanagere KARNATAKA 577004 India |
| Phone |
9886593224 |
| Fax |
|
| Email |
Gayathri_dental@rediffmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Gayathri G V |
| Designation |
Professor and Head |
| Affiliation |
Bapuji Dental College and Hospital |
| Address |
Room no 5, Department of Periodontics, Bapuji Dental College and Hospital, MCC B Block, Davangere- 577004
Davanagere KARNATAKA 577004 India |
| Phone |
9886593224 |
| Fax |
|
| Email |
Gayathri_dental@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Bapuji Dental College and Hospital, Davangere 577004 |
|
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Primary Sponsor
|
| Name |
Anusha K |
| Address |
Department of Periodontics, Bapuji Dental College and Hospital, Davangere 577004 |
| Type of Sponsor |
Research institution and hospital |
|
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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 |
| Dr Anusha K |
BAPUJI DENTAL COLLEGE AND HOSPITAL |
ROOM NO 5, DEPARTMENT OF PERIODONTICS, BAPUJI DENTAL COLLEGE AND HOSPITAL, MCC B Block, MCC, Davangere- 577004, KARNATAKA, INDIA Davanagere KARNATAKA |
09845432616
anushaanu2628@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL REVIEW BOARD, BAPUJI DENTAL COLLEGE AND HOSPITAL, DAVANGERE- 577004 |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LOW LEVEL LASER AND LOW LEVEL LASER+ ALBUMIN PLATELET RICH FIBRIN(ALB-PRF) |
9 ml of whole blood will be collected from antecubital fossa in S-PRF tube without any anti-coagulant. It will be placed in the centrifuge, along with a tube filled with water in order to maintain the balance and centrifuged for 8 minutes at 2700 rpm (~ 700 x g). Now, the tube will contain plasma and the decanted blood material. Of this, about 2 ml of the topmost part called platelet poor plasma (PPP) shall be extracted with a syringe, while the rest of the blood contents will be preserved at a cool temperature. Subsequently, the syringe containing platelet poor plasma (PPP) will be heated for 10 minutes at a temperature of 75 degree C and tube will be left for 10 minutes at room temperature. After that, the cooled albumin gel on the glass container will be combined with the liquid PRF, which contains remaining cells as well as growth factors from the layer of buffy coat, to create Alb- PRF. After fibrin polymerization process (approximately 5 minutes), the processed mixture was turned into an Alb- PRF membrane that was deemed appropriate for use. This product will ultimately be used in the defect site following open flap debridement and Low-level laser therapy. |
| Intervention |
OPEN FLAP DEBRIDEMENT |
All patients will be operated under local anaesthetic agent (2percent lignocaine containing 1/80,000 adrenaline). Anaesthesia will be administered by either nerve block or local infiltration.
First, sulcular incisions will be made at both sites, and then interdental incisions will be made as part of OFD. After the full-thickness flap is reflected, a comprehensive debridement procedure will be performed.
Group A sites will be treated with open flap debridement followed by Low-level laser therapy.
Low-level laser therapy2:
On every surface, a continuous mode diode laser with a 2 watt power setting will be operated at 970 nm wavelength for 10 seconds. Using a 320 micro meter diameter laser tip, overlapping strokes horizontally from the border to the bottom of the lingual or palatal and labial or buccal flaps will be used to lase the interior aspect of the flap. By aiming the laser beam at 45 degrees toward the flap, care will be made to avoid contact of laser with the alveolar bone and root surface.
Group B sites will receive open flap debridement, albumin-PRF and low-level laser therapy in order of treatment. A simple interrupted suturing approach will be used to approximate the flaps using 4-0 black silk sutures.
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Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who are systemically healthy.
2. Patients having minimum two sites in different quadrants with periodontal probing pocket depth (PPD) greater than or equal to 6mm and clinical attachment loss (CAL) greater than or equal to 3mm, having horizontal type of bone loss radiographically.
|
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| ExclusionCriteria |
| Details |
1. Patients with the habits like smoking (current smokers), alcohol consumption and with systemic diseases like uncontrolled diabetes, hypertension, atherosclerosis, etc.
2. Patients with any periapical infections or large carious lesions.
3. Patients with history of antibiotics usage (within 3 months), or history of periodontal surgery in last six months.
4. Patients who are allergic to medications prescribed post- surgically.
5. Pregnant and lactating women.
6. Patients who exhibit non-compliant behaviour or physical disabilities.
7. Patients who cannot maintain oral hygiene or not available for follow up.
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|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
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Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To assess Low- level laser therapy as an adjunct to open flap debridement on clinical parameters and GCF Interleukin-1beta level in chronic periodontitis patients |
4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess Low- level laser therapy as an adjunct to open flap debridement with Albumin platelet-rich fibrin on clinical parameters and GCF Interleukin-1beta level in chronic periodontitis patients |
4 months |
|
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Target Sample Size
|
Total Sample Size="30" Sample Size from India="30"
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)
|
24/01/2026 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
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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 the primary cause for tooth loss which is described by the progressive deterioration of alveolar bone and connective tissue attachment. Periodontal therapy aims at arresting infection, restoring the lost tooth supporting structures and to maintain a healthy periodontium either by surgical/ non-surgical modalities. Among them, the goal of periodontal surgery is to alleviate the degeneration associated with the sites inaccessible for non-surgical therapy and having critical probing depth of greater than or equal to 5.4mm in progressive periodontal disease. In order to accomplish this, access to the underlying root and bone surface for debridement has been an integral part of periodontal surgical therapy known as open flap debridement (OFD). This mechanical treatment alone will not be able to eliminate tissue invasive periodontal pathogens, which serve as nidus for recolonization and reinfection in the treated sites. Thus, to overcome these limitations, use of adjunctive modalities like antimicrobials, host-modulating agents, anti- inflammatory agents and autologous platelet concentrates have been used with variable results. Diode laser with wavelength of 910- 980 nm is found to target the soft tissue which is diseased but without affecting the dental hard tissues. Increased reduction in colony forming unit (CFU) of obligate anaerobes were detected in low- level laser (LLLT) treated sites as an adjunct to flap surgery. Adequate sterilization, haemostasis and reduced inflammation, increases periodontal tissue attachment and less post- operative pain has been observed in surgical procedure with diode laser compared to that of conventional surgical therapy. The second generation of platelet concentrates, known as platelet rich fibrin, is used as an autologous biological scaffold for periodontal therapy. PRF in conjunction with OFD showed improved clinical attachment level (CAL) as well as probing pocket depth (PPD) post-surgically. Intra-marrow penetration has synergized the effect of PRF matrix, aiding in periodontal regeneration of horizontal defect. Among the PRFs, the newest Albumin- PRF has shown increased membrane stability for 4-6 months and enhanced wound healing by gradual release of growth factors. It also expressed increased fibroblast proliferation than i-PRF and clinically reduced oedema and decreased release of pro- inflammatory cytokines than L-PRF. Biomarkers validate the best estimate of the prognosis unique to a site and the outcome of periodontal therapy. Hence, increased and decreased levels of these biomarkers become a significant tool in assessing the biological events that occur at molecular level in the pocket lining. When compared to healthy regions, it is discovered that the diseased periodontal tissues and gingival fluid have noticeably higher concentrations of the pro-inflammatory cytokine interleukin-1. Significant reduction in IL-1beta level was observed in chronic periodontitis patients following laser- assisted non-surgical therapy. The most frequent issue confronting clinicians is chronic periodontitis with horizontal bone loss, although this condition has attracted very little attention. Till date, studies have shown improved clinical parameters by reduced inflammation with the use of lasers and better clinical and radiographic bone levels when PRF was used as an adjunct to OFD compared to OFD alone. As much as we are aware, no research has been done so far to assess the synergistic effect of low- level laser therapy and Alb-PRF in horizontal defect following open flap debridement. Hence, the aim of this study is to evaluate the effect of low- level laser therapy as an adjunct to open flap debridement with and without albumin- platelet rich fibrin on clinical parameters and gingival crevicular fluid interleukin-1beta level in chronic periodontitis patients. | |