| CTRI Number |
CTRI/2026/03/105781 [Registered on: 10/03/2026] Trial Registered Prospectively |
| Last Modified On: |
10/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Evaluating the benefits of 1% melatonin usage in participants with periodontal bone loss so that there will be bone growth |
|
Scientific Title of Study
|
Comparing regenerative potential of 1% Melatonin and Leukocyte-platelet rich fibrin (L-PRF) when used in treatment of periodontal defects – a Split mouth Clinico-Radiographic 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 kanike shravanth |
| Designation |
PG student |
| Affiliation |
Government dental collage and hospital Hyderabad |
| Address |
Department of Periodontics Room no.317, 2nd floor Government
Dental College and Hospital, AfzalGunj, Osmania General
Hospital Campus, Hyderabad, Telangana, 500012
Hyderabad
Hyderabad
TELANGANA
500012
India |
| Phone |
8341856647 |
| Fax |
|
| Email |
shravanth2k@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Harikrishna Reddy |
| Designation |
Associate Professor |
| Affiliation |
Government dental collage and hospital Hyderabad |
| Address |
Department of Periodontics Room no.317, 2nd floor , Osmania
General Hospital Campus, Afzal Gunj, Hyderabad, Telangana,
500012
Hyderabad
TELANGANA
500012
India |
| Phone |
9989989876 |
| Fax |
|
| Email |
shkreddy9@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
kanike shravanth |
| Designation |
PG student |
| Affiliation |
Government dental collage and hospital Hyderabad |
| Address |
Department of Periodontics Room no.317, 2nd floor , Osmania
General Hospital Campus, Afzal Gunj, Hyderabad, Telangana,
500012
Hyderabad
TELANGANA
500012
India |
| Phone |
8341856647 |
| Fax |
|
| Email |
shravanth2k@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Self sponsor |
| Address |
7-53/3/C, Bala Saraswathi Nagar,
Near Ambedkar Statue Malkajgiri
HYDERABAD |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 |
| k shravanth |
Government dental college and hospital Hyderabad |
Department of Periodontics Room no.317, 2nd floor Government
Dental College and Hospital, AfzalGunj, Osmania General
Hospital Campus, Hyderabad, Telangana,500012 Hyderabad
Hyderabad
TELANGANA |
8341856647
shravanth2k@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1% melatonin granules |
Access flap is elevated L- Prf loaded with 1% melatonin granules will be placed in intra bony defect after debridement of the site and is sutured along with pack placement |
| Comparator Agent |
L-Prf |
Access flap is elevated plain L-Prf is used as comparator like placebo in intra bony defect after debridement of the site and is sutured along with pack placement |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
patient with no systemic disease ,probing pocket depth of 5 to 9 mm and horizontal defect depth of 3 to 5 mm |
|
| ExclusionCriteria |
| Details |
Patients with poor compliance.
Patients with smoking habit.
Pregnancy and lactation.
Patients with any systemic disease
Patients with Blood disorders
Patients under any medication which alter the bone metabolism
Patients with malocclusion and parafunctional habits.
CBCT evaluation showing defect not suitable for grafting procedures |
|
|
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 |
| melatonin group show good bone fill |
melatonin group show good bone fill at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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 4 |
|
Date of First Enrollment (India)
|
20/03/2026 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
There are studies evaluating
efficiency of L-PRF in periodontal regeneration in intrabony defects .
There are no particular studies till date
which compared the regenerative potential of Melatonin V/S LPRF in intrabony defects caused due to
periodontitis.
This
study is done to observe the amount of bone fill obtained when 1% melatonin is
used to treat intrabony periodontal defects.
The aim
of the present study is to compare
and evaluate the regeneration of bone by using 1% Melatonin against L-PRF in periodontal intrabony defects using clinical and
radiographic parameters |