| CTRI Number |
CTRI/2025/09/095031 [Registered on: 18/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A study to compare vitamin C with microneedling and platelet-rich fibrin with microneedling for the treatment of interdental papilla (black triangle) defects in the front teeth. |
|
Scientific Title of Study
|
Comparative evaluation of the efficacy of injectable platelet-rich fibrin with microneedling versus vitamin C injection with microneedling in the treatment of Class I interdental papilla defects: A randomized 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 |
Dr Sai kamali Mandava |
| Designation |
Postgraduate Student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
COORG INSTITUE OF DENTAL SCIENCE DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY ROOM 4 K K CAMPUS MAGGULA VIRAJPET KARNATAKA KODAGU
COORG INSTITUE OF DENTAL SCIENCE DEPARTMENT OF PERIODONTICS AND IMPLANTOLOGY ROOM 4 K K CAMPUS MAGGULA VIRAJPET KARNATAKA KODAGU
Kodagu
KARNATAKA
571218
India |
| Phone |
08328348424 |
| Fax |
|
| Email |
dr.kamalibds22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sai kamali Mandava |
| Designation |
Post Graduate student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Room 4, K. K. Campus, Maggula, Virajpet, Kodagu, Karnataka, India.
Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Room 4, K. K. Campus, Maggula, Virajpet, Kodagu, Karnataka, India.
Kodagu
KARNATAKA
571218
India |
| Phone |
08328348424 |
| Fax |
|
| Email |
dr.kamalibds22@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Amit Walvekar |
| Designation |
Head of the Department, Department of Periodontics and Implantology, Coorg Institute of Dental Sciences, Virajpet, Karnataka, India. |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Room 4, K. K. Campus, Maggula, Virajpet, Kodagu, Karnataka, India.
Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Room 4, K. K. Campus, Maggula, Virajpet, Kodagu, Karnataka, India.
Kodagu
KARNATAKA
571218
India |
| Phone |
9480085687 |
| Fax |
|
| Email |
amitakw@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Room 4, K. K. Campus, Maggula, Virajpet, Kodagu, Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Dr Sai kamali Mandava |
| Address |
Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Room 4, K. K. Campus, Maggula, Virajpet, Kodagu, Karnataka, India. |
| 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 |
| DrSai kamali Mandava |
coorg institue of dental sciences |
Coorg Institute of Dental Sciences, Department of Periodontics and Implantology, Room 4, K. K. Campus, Maggula, Virajpet, Kodagu, Karnataka, India.
Kodagu
KARNATAKA |
8328348424
dr.kamalibds22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instutional review board,coorg institute of dental sciences |
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 |
Vitamin C Injection with Microneedling |
Type: Drug (Vitamin C)
Route of administration: Intra-papillary injection following microneedling
Dosage / Regimen:
Microneedling performed in interdental papilla using 30G lancet needles (~250 microchannels/cm²).
Vitamin C (ascorbic acid solution) injected at 45° angle, 2–3 mm apical to |
| Intervention |
Injectable Platelet-Rich Fibrin with Microneedling |
Type: Biological (autologous platelet concentrate) + procedure
Route of administration: Intra-papillary injection after microneedling
Description:
10 mL of venous blood will be withdrawn from the antecubital vein.
Blood will be centrifuged at 700 rpm for 3 minutes (plastic tubes, no anticoagulants) to obtain ~1 mL I-PRF.
Microneedling will be performed in the interdental papilla region using 30G lancet needles to create ~250 microchannels per cm².
Immediately after, I-PRF will be injected into the papilla region using an insulin syringe.Dosage / Frequency: Intervention given at baseline; repeated at 3-week intervals if required.
Duration of intervention: 12 weeks follow-up. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged 18 to 45 years (both genders).
Presence of at least one Nordland and Tarnow Class I interdental papilla defect in the maxillary anterior region.
Selected teeth free of restorations on cervical or proximal surfaces.
Patient reports food lodgment or esthetic concern due to open gingival embrasure.
Distance between interproximal contact point and alveolar bone crest less than or equal to 7 mm. |
|
| ExclusionCriteria |
| Details |
Patients with history of traumatic occlusion.
Systemically unhealthy or medically compromised patients.
Patients with implants or endodontically treated teeth in the involved area.
Pregnant or lactating women.
Smokers or alcoholics. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in papilla defect height mm measured on standardized intraoral photographs. |
baseline 3 weeks 6 weeks and 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in papilla width mm papilla deficient area mm² papilla deficient volume (mm³), & patient-reported esthetic satisfaction (VAS score). |
baseline 3 week 6 weeks & 12 weeks |
| nill |
nill |
|
|
Target Sample Size
|
Total Sample Size="22"
Sample Size from India="22"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/10/2025 |
| 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 Applicable |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [dr.kamalibds22@gmail.com].
- For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Interdental papilla loss in the anterior esthetic region results in gingival black triangles, which cause esthetic concerns, food lodgment, and plaque retention. Conventional surgical procedures for papilla reconstruction are invasive and unpredictable, while nonsurgical fillers such as hyaluronic acid require repeated applications and increase treatment cost. Injectable Platelet-Rich Fibrin (I-PRF) is a leukocyte-enriched autologous platelet concentrate that promotes wound healing, collagen formation, and antimicrobial activity. Microneedling enhances delivery of biologics, induces neovascularization, and stimulates collagen induction. Vitamin C plays a critical role in collagen biosynthesis, fibroblast proliferation, and periodontal healing, and when combined with microneedling may further improve papilla regeneration. The present randomized clinical trial aims to compare the clinical efficacy of I-PRF with microneedling versus Vitamin C with microneedling in the treatment of Class I interdental papilla defects in the maxillary anterior region. The study will evaluate changes in papilla defect height (primary outcome), papilla width, deficient area, deficient volume, and patient-reported esthetic satisfaction (secondary outcomes) over a 12-week follow-up period. |