| CTRI Number |
CTRI/2022/12/048262 [Registered on: 19/12/2022] Trial Registered Prospectively |
| Last Modified On: |
16/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of systemic melatonin in periodontal therapy |
|
Scientific Title of Study
|
Evaluation of the effect of systemically administered melatonin in patients undergoing regenerative surgical periodontal therapy- a double blind placebo controlled clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Iram Rafique Pawane |
| Designation |
Resident |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 25,
Department of Periodontics and Oral Implantology,
Saveetha Dental College and Hospitals
Opp. Aravind eye hospital,
Poonamallee high road
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9619245546 |
| Fax |
|
| Email |
iramrafique2396@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sankari Malaiappan |
| Designation |
Professor (MDS,PhD) |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 25,
Department of periodontics and oral implantology
Saveetha Dental College and Hospitals
Opp. Aravind eye hospital,
Poonamallee high road
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840285905 |
| Fax |
|
| Email |
Sankari@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sankari Malaiappan |
| Designation |
Professor |
| Affiliation |
Saveetha Dental College and Hospitals |
| Address |
Clinic 25
Department of periodontics and oral implantology
Saveetha Dental College and Hospitals
Opp. Aravind eye hospital,
Poonamallee high road
Chennai
Thiruvallur
TAMIL NADU
600077
India |
| Phone |
9840285905 |
| Fax |
|
| Email |
sankari@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha Dental College And Hospitals, Saveetha University |
|
|
Primary Sponsor
|
| Name |
Other self |
| Address |
Saveetha Dental College and Hospitals, Poonamallee high road
Chennai 600077 |
| 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 |
| Iram Rafique Pawane |
Saveetha Dental College and Hospitals |
Poonamallee high road
Opp. Aravind eye hospital
Chennai
Thiruvallur
TAMIL NADU |
9619245546
iramrafique2396@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Saveetha research board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M278||Other specified diseases of jaws, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Melatonin |
Melatonin 3 mg, systemically administered once a day after food in the night for 30 days |
| Comparator Agent |
Placebo |
Sugar tablet as placebo, taken once a day after food in the night for 30 days; similar to intervention group. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.systemically healthy Subjects with periodontal disease indicated for flap surgery
2. Subjects with three/two walled intrabony defects that can be regenerated
|
|
| ExclusionCriteria |
| Details |
1. Subjects without periodontal disease
2. Subjects with periodontal disease not requiring regenerative therapy
|
|
|
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 |
| Level of alkaline phosphatase and bone sialoprotein at baseline and 4 weeks after intervention |
at baseline and 4 weeks after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Levels of melatonin |
Baseline, 1 month |
| Clinical parameters: probing depth, clinical attachment loss |
Base line, 3 months |
|
|
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)
|
25/12/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Melatonin is secreted by the pineal gland in circadian cycles, mainly during sleep. However, a small portion is also produced by the salivary glands. Therefore, we chose melatonin to test if it might contribute to the prevention of severe oral inflammation and improve the bone regeneration compared to patients without melatonin supplementation.
|