| CTRI Number |
CTRI/2025/09/094594 [Registered on: 11/09/2025] Trial Registered Prospectively |
| Last Modified On: |
09/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating efficacy of blood derived substitutes along with laser in the treatment of gum disease. |
|
Scientific Title of Study
|
Platelet-Rich Fibrin as an Adjunct to Laser Assisted New Attachment Procedure in the treatment of Periodontitis: Clinical Outcomes from a Randomized 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 A Geetha Sahithi |
| Designation |
Postgraduate student |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore. ANDHRA PRADESH Nellore ANDHRA PRADESH 524003 India |
| Phone |
9392971172 |
| Fax |
|
| Email |
sahithiallampati@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sreenivas Nagarakanti |
| Designation |
Professor and Head of the department |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore. ANDHRA PRADESH Nellore ANDHRA PRADESH 524003 India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sreenivas Nagarakanti |
| Designation |
Professor and Head of the department |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore. ANDHRA PRADESH Nellore ANDHRA PRADESH 524003 India |
| Phone |
9985664566 |
| Fax |
|
| Email |
sreenivasnagarakanti@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.A.Geetha Sahithi,Department of Periodontology,Room no.5, Narayana Dental College and Hospital,Chintareddypalem,Nellore-524003 |
|
|
Primary Sponsor
|
| Name |
Dr A Geetha Sahithi |
| Address |
Department of Periodontology,Room no.5, Narayana Dental College and Hospital,Chintareddypalem,Nellore-524003 |
| Type of Sponsor |
Other [self- principal investigator] |
|
|
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 A Geetha Sahithi |
Narayana Dental College and Hospital |
Department of Periodontology, Room no-5,Narayana Dental College and Hospital,Chintareddypalem,Nellore.
ANDHRA PRADESH
INDIA Nellore ANDHRA PRADESH |
9392971172
sahithiallampati@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NarayanaDentalCollegeandHospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Laser assisted new attachment procedure(LANAP) |
scaling and rootplaning will be performed in patients with periodontal pockets greater than 5 mm.After scaling and root planing LANAP will be applied in control group.participants are evaluated at o,3,6 months for parameters like clinical attachment loss, probing depth ,bleeding on probing and visual analogue scale and compared with test group |
| Intervention |
Laser assisted new attachment procedure(LANAP)+ Platelet rich fibrin(PRF) |
scaling and rootplaning will be performed in patients with periodontal pockets greater than 5 mm.After scaling and root planing LANAP+PRF will be applied in test group.participants are evaluated at o,3,6 months for parameters like clinical attachment loss,probing depth bleeding on probing and visual analogue scale |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals.
Participants with age group of 18 to 55 years.
Participants with stage 2 and stage 3
periodontitis, and presence of at least one
tooth at each side of the mouth with one
residual pocket (PPD more than 5mm after phase 1
therapy). |
|
| ExclusionCriteria |
| Details |
Systemic diseases
Pregnancy and Lactating women
Recent antibiotic use
Using tobacco in any form. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Probing depth(PD)
Clinical attachment level(CAL)
|
Baseline, 3 months,6 months)
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Bleeding on probing(BOP)
Patient pain perception by visual analogue scale(VAS) |
Baseline, 3 months,6 months |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
01/12/2025 |
| 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="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
|
Patients with stage2, stage3 periodontitis will be selected from the outpatient department of Periodontology, based on inclusion and exclusion criteria. Participants with probing pocket depth of 5 mm in atleast one tooth at each side of the mouth with one residual pocket will be selected.
Fourty four participants will be selected and randomly assigned to test and control sites by computer generated randomization method.
Clinical attachment level, probing pocket depth, bleeding on probing and patient pain perception by visual analogue scale will be recorded at baseline, 3 months and 6 months.
After scaling and root planing of the selected sites in both groups. Patients will be asked to return after one week for an assessment of their oral hygiene practices and additional procedures. Two quadrants with deep periodontal pockets will be chosen in each participant. The control areas will undergo LANAP treatment alone where this procedure will be done under local anesthesia. An optic fiber tip of Diode laser measuring 0.3s is placed parallel to the root surface, to carry away the epithelium lining of the pocket in coronal to apical motion to reflect the gingival flap. The first pass laser or troughing dissipates energy at 4 W, free running 100 milliseconds pulse expels the unhealthy lining of the pocket, and the pocket is closed by compressing gingival tissues against the root surface which creates a firm fibrin clot. While the test areas will receive a combination of LANAP and PRF. The prepared PRF will be compressed to a 1 mm thickness using gentle pressure between sterile tongue depressors. The flattened PRF will then be cut into smaller pieces and inserted into the periodontal pocket, filling it from the bottom to the gum line. A dull interdental gingivectomy knife will be employed to place the PRF membrane within the pocket. |