| CTRI Number |
CTRI/2024/08/072491 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Regrowth of gum tissue by using laser treatment and self generated blood products. |
|
Scientific Title of Study
|
Comparative Evaluation of Hemolasertherapy with and without injectable platelet rich fibrin in papillary reconstruction-A Randomised clinical 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 |
RUPAVATH SUPRIYA |
| Designation |
POST GRADUATE |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no-5,Department of Periodontology,
Narayana Dental College and Hospital,
Chintareddypalem, Nellore,
Andhra Pradesh,524003.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9640841830 |
| Fax |
|
| Email |
supriyar916@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR. GUNUPATI SUMANTH |
| Designation |
PROFESSOR |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no-5,Department of Periodontology,
Narayana Dental College and Hospital,
Chintareddypalem, Nellore,
Andhra Pradesh,524003.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
|
| Fax |
|
| Email |
sumant29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR.GUNUPATI SUMANTH |
| Designation |
PROFESSOR |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Room no-5,Department of Periodontology,
Narayana Dental College and Hospital,
Chintareddypalem, Nellore,
Andhra Pradesh,524003.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
|
| Fax |
|
| Email |
sumant29@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. R.Supriya,
Department of Periodontology,Narayana Dental College and Hospital, Chintareddypalem, Nellore,Andhrapradesh 524003 |
|
|
Primary Sponsor
|
| Name |
RUPAVATH SUPRIYA |
| Address |
Room no -5,Narayana Dental College and Hospital,
Chintareddypalem, Nellore,
Andhrapradesh-524003
|
| Type of Sponsor |
Other [Self funded] |
|
|
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 |
| Rupavath Supriya |
Narayana Dental College and Hospital |
Room no-5,Department of Periodontology,Chintareddypalem,
Nellore, Andhra Pradesh-524003
Nellore
ANDHRA PRADESH |
9640841830
supriyar916@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE, NARAYANA DENTAL COLLEGE AND HOSPITAL |
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 |
Hemolasertherapy without injectable platelet rich fibrin. |
Interdental papillary regeneration and clinical parameters plaque index and gingival index at baseline,1month and 6months are assesed with hemolasertherapy only. |
| Intervention |
Hemolasertherapy with injectable platelet rich fibrin. |
entire procedure will be performed under local anaesthesia and aseptic conditions. On the interdental papilla either maxillary or mandibular teeth hemolasertherapy will be performed.At the interdental papilla the injectable platelet rich fibrin is injected which is derived from patients blood. This procedure is carried out for 2 times at the same site at an interval of 7days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-50 years.
Patients with class1 and class2 [Nordland and Tarnow Classificatioin] anterior interdental papillary loss.
Non-Smoker patients.
Plaque and gingival index score between 0-1.
Pateints who are co-operative and able to come for regular checkup. |
|
| ExclusionCriteria |
| Details |
patients with bleeding gums and edematous gums.
patients with systemic diseases.
consumption of drugs causing gingival hyperplasia.
patients with periodontal pocket.
pregnant and lactating patients.
patients with caries,proximal restoration,fixed prosthesis and orthodontic appliance. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare the interdental papillary gain. |
baseline,1month and 6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
plaque index(sillness &loe,1964)
gingival index(loe &sillness 1963) |
baseline,1month and 6months |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
20/08/2024 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
AIM: The aim of the present study to compare and evaluate the effect of hemolasertherapy alone and hemolasertherapy in combination with injectable platelet rich fibrin for papillary regeneration. All the participants will be explained about the aim ,nature and design of study along with a written informed consent for their participation before the commencement of the study. This study is planned as a randomized clinical trial conducted in healthy individuals with anterior interdental papillary loss. The study duration is 6 months in which clinical parameters will be recorded at baseline,1,6 months. All the patients included in study will be evaluated before the treatment procedure and patients with anterior interdental papillary loss in either maxilla or mandible are selected. PREPARATION OF INJECTABLE PLATELET RICH FIBRIN:Before the procedure ,a venous blood sample will be collected for each patient using a syringe and taken into I-PRF tubes of 10ml containing no anticoagulants and will be centrifuged at room temperature for3min at 700rpm. HEMOLASERTHERAPY: applied with a diode laser in 2 stages :before bleeding and immediately after bleeding. bleeding points were marked on gingiva with a tissue marker . 3 points per tooth and a point between labial and lingual papilla. each spot was irradiated with 980nm diode laser at a power setting 100mW FOR 20SECONDS/ maximum energy of 20J per point. At the base of papilla , fiber tip was inserted approximately 3-4mm into interdental papilla and irrradiated at the same poweer setting. pricks were made on goingiva with explorer tip on every bleeding point marked. The blood was allowed to flow into the sulcus and interdental embrassure,then irradiated with same power setting. HEMOLASERTHERAPY + INJECTABLE PLATELET RICH FIBRIN: After hemolasertherapy procedure is completed in keratinizedtissue, injectable platelet rich fibrin will be injected into interdental papilla. The clinical measurements of patients will be taken once at baseline then after 1month and 6 months. |