| CTRI Number |
CTRI/2024/04/066082 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of additive efficacy of filler material hyaluronic acid combined with melatonin to close black triangle formed in between the teeth after gum surgery. |
|
Scientific Title of Study
|
Evaluation of Additive Efficacy of Hyaluronic acid with Melatonin gel in papilla reconstruction post flap surgery. |
| 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 Nivedha N |
| Designation |
PG student |
| Affiliation |
|
| Address |
Clinic 25, 4th floor,
Department of Periodontology,
Saveetha dental college and Hospital,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai-77.
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9600177122 |
| Fax |
|
| Email |
152205003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sankari Malaiappan |
| Designation |
Professor |
| Affiliation |
Saveetha dental college and hospital, SIMATS University |
| Address |
Clinic 25, 4th floor,
Department of Periodontology,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai
Kancheepuram
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 hospital, SIMATS University |
| Address |
Clinic 25, 4th floor,
Department of Periodontology,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai
TAMIL NADU
600077
India |
| Phone |
9840285905 |
| Fax |
|
| Email |
sankari@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospital, Saveetha Institute of Medical and Technical Sciences |
|
|
Primary Sponsor
|
| Name |
Saveetha Dental College and Hospital SIMATS university |
| Address |
Clinic 25, 4th floor,
Department of Periodontology,
Saveetha dental college and hospital, SIMATS university.
No 162, Poonamallee High Road,
Chennai 600077 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Nivedha N |
Clinic 25, 4th floor,
Department of Periodontology,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai 600077. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nivedha N |
Saveetha dental college and hospital, Saveetha Institue of Medical and Technical Sciences |
Clinic 25, 4th floor,
Department of Periodontology,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Vellapanchavadi, Chennai 600077
Kancheepuram
TAMIL NADU |
9600177122
152205003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyaluronic acid |
Hyaluronic acid (0.8% Gengigel) introduced into the maxillary or mandibular anterior interdental papilla area by subperiosteal tunneling technique at the time of surgical procedure.
|
| Intervention |
Hyaluronic acid+ melatonin |
Hyaluronic acid (0.8% Gengigel) used with 3mg of melatonin powder to be measured using a laboratory weight measuring instrument mixed and introduced into the maxillary or mandibular anterior interdental papilla area by subperiosteal tunneling technique at the time of surgical procedure.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients among 18 – 45 years of age who has undergone flap surgery within 3 months of interval.
2 Patients with esthetic concern;
3 Having adequate width of attached gingiva
4 The sites with a distance 7 mm from the interdental contact point to the interproximal bone crest and a probing depth of 4 mm at the defective papillary sites were considered for inclusion.
5 Food lodgment in the anterior embrasure;
with Class I and Class II papillary loss (Nordland & Tarnow classification, 1982) |
|
| ExclusionCriteria |
| Details |
1 Patient who received radiotherapy, chemotherapy, immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to intervention.
2 Patients with known history of allergy having
known history of allergy, systemic or blood borne diseases undergoing orthodontic treatment.
3 prolonged treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or similar medications.
4 smokers; lactating or pregnant females.
5 presence of any restoration in maxillary or mandibular anterior region |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Papillary Width
Papillary Deficient Height
Width of keratinized gingiva
Deficient Area |
Baseline
3months
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Probing depth
Clinical attachment levels
Plaque index
Papilla presence index |
Baseline
3months
6months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="13" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| Date of Study Completion (India) |
27/04/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Open flap debridement is a gold standard treatment for treatment of periodontitis but often creates black triangle. Loss of interdental papilla then becomes a sequale of flap surgeries. Hyaluronic acid is potent in soft tissue augmentation as they are insoluble, resist degradation, does not migrate and retain water content. Melatonin increases VEGF expression, which is a potent angiogenic modulator by exerting a significant pro angiogenic activity. It has antioxidant , anti microbial property that might help in repair of both soft and hard tissue. It also stimulates collagen type I proliferation.Thus, use of melatonin with hyaluronic acid in treatment of papilla reconstruction might provide with better outcomes. This study aims to determine the papilla reconstruction using hyaluronic acid and melatonin combination post flap surgery. |