| CTRI Number |
CTRI/2025/09/095434 [Registered on: 26/09/2025] Trial Registered Prospectively |
| Last Modified On: |
25/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological Surgical/Anesthesia Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A split-mouth study comparing i-PRF with microneedling and low-level laser therapy on postoperative healing after open flap debridement in stage III periodontitis |
|
Scientific Title of Study
|
Comparative evaluation of i-prf with micro-needling and
low-level laser application on post operative healing associated
with open flap debridement in the treatment of stage iii periodontitis:
A split mouth 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 K SUNEETHA |
| Designation |
PROFESSOR |
| Affiliation |
Drs. Sudha and Nageswara rao Siddartha institute of dental sciences |
| Address |
Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal Krishna ANDHRA PRADESH 521286 India |
| Phone |
9290574051 |
| Fax |
|
| Email |
konerusuneetha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
N. Tejaswini |
| Designation |
PG student |
| Affiliation |
Drs. Sudha and Nageswara rao Siddartha institute of dental sciences |
| Address |
Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal Krishna ANDHRA PRADESH 521286 India |
| Phone |
9014726887 |
| Fax |
|
| Email |
tejaswini07n@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr K SUNEETHA |
| Designation |
PROFESSOR |
| Affiliation |
Drs. Sudha and Nageswara rao Siddartha institute of dental sciences |
| Address |
Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal Drs Sudha and Nageswara rao siddartha institute of dental sciences, Department of periodontics and implantology room no. 3 chinnaoutapalli Gannavaram mandal Krishna ANDHRA PRADESH 521286 India |
| Phone |
9290574051 |
| Fax |
|
| Email |
konerusuneetha@gmail.com |
|
|
Source of Monetary or Material Support
|
| Drs. Sudha & Nageswara Rao Siddhartha Institute of Dental Sciences, Chinnaoutapalli, Gannavaram mandal, Krishna district, Andhrapradesh, India, PINCODE:521286 |
|
|
Primary Sponsor
|
| Name |
Tejaswini N |
| Address |
Drs Sudha and Nageswara Rao Siddhartha Institute Of dental Sciences Room Number 3 Department of periodontics and Implantology Chinnaoutpalli Gannavaram
Chinnaoutpalli
Krishna
ANDHRA PRADESH
521286
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 Tejaswini N |
Drs. Sudha and Nageswararao Siddartha institute of dental scinences |
Department of Periodontics and Implantology room no. 3
Krishna ANDHRA PRADESH |
9014726887
tejaswini07n@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee Drs Sudha and Nageswara rao siddartha institute of dental sciences |
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 |
Diode laser |
open flap debridement followed by irradiation with low level diode laser having wavelength of 980nm & power 0.5W for 10 secs per each tooth in continuous non-contact mode. |
| Intervention |
I- PRF with microneedling |
open flap debridement followed by microneedling on inner aspect of flap & injectable platelet rich fibrin application |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals.
Patients with Stage-III, Grade-A periodontitis
Bilateral pockets with probing pocket depth greater than or equal to 6mm involving at least two or three teeth post phase-I therapy.
|
|
| ExclusionCriteria |
| Details |
History of antibiotic therapy within 6months.
Uncooperative patients.
Poor oral hygiene.
Smokers.
Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Plaque index
Gingival index
|
at baseline, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Landry wound healing index |
7th day, 14th day, 1 month. |
| Probing pocket depth, Clinical attachment level, Gingival thickness |
baseline & 3 months. |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
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 |
|
Date of First Enrollment (India)
|
09/10/2025 |
| 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="2" Months="0" Days="0" |
|
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
|
Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth, including the gingiva, periodontal ligament, and alveolar bone. It is primarily initiated by a dysbiotic bacterial biofilm but perpetuated by an exaggerated host immune response, leading to progressive tissue destruction and eventual tooth loss if untreated. The management of periodontitis aims to eliminate the microbial etiology, reduce inflammation, halt disease progression, and restore periodontal health. Initial therapy typically involves non-surgical approaches such as scaling and root planing combined with improved oral hygiene practices. In cases with persistent deep pockets or advanced disease, surgical interventions like open flap debridement, regenerative procedures, and use of biologics (such as platelet concentrates or growth factors) are employed to gain better access for debridement, facilitate tissue regeneration, and improve long-term outcomes. Injectable platelet-rich fibrin (i-PRF) is a concentrated autologous preparation rich in growth factors that promotes tissue regeneration and healing. When combined with micro-needling on the inner aspect of the flap (the connective tissue side), it enhances penetration and release of growth factors into the surgical site. This approach may accelerate soft-tissue healing, reduce post-operative inflammation, and improve clinical outcomes such as pocket depth reduction and attachment gain compared to flap surgery alone. Low-level laser therapy (LLLT) applied to the inner aspect of the flap during periodontal surgery enhances bio-stimulation, promoting faster and better-quality healing. By stimulating fibroblast activity, collagen production, angiogenesis, and reducing inflammation, LLLT improves tissue regeneration and reattachment to root surfaces. |