| CTRI Number |
CTRI/2025/07/091422 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A study in adults to compare three treatments for rebuilding the lost gum between teeth using injectable platelet rich fibrin autologous fibrin glue and hyaluronic acid gel
|
|
Scientific Title of Study
|
Comparative evaluation of Injectable Platelet Rich Fibrin, Autologous Fibrin Glue and Hyaluronic Acid Gel for papilla reconstruction; A randomised clinical trial
|
| Trial Acronym |
nill |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anjali Devi Patel |
| Designation |
JR1 MDS |
| Affiliation |
Faculty of Dental Sciences,IMS,BHU,Varanasi |
| Address |
Department of Periodontics,3rd Floor, Room no 5, Faculty of Dental Sciences IMS, BHU, Varanasi.
Department of Periodontics,3rd Floor, Room no 5, Faculty of Dental Sciences IMS, BHU, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376080315 |
| Fax |
|
| Email |
anjalipatel3713@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sarita Parihar |
| Designation |
Professor |
| Affiliation |
Faculty of dental sciences, IMS, BHU,Varanasi |
| Address |
Department of Periodontics,3rd Floor, Room no 5, Faculty of Dental Sciences IMS, BHU, Varanasi, pin code 221005
Department of Periodontics,3rd Floor, Room no 5, Faculty of Dental Sciences IMS, BHU, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8004925677 |
| Fax |
|
| Email |
drsarita6@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Anjali Devi Patel |
| Designation |
MDS JR1 |
| Affiliation |
Faculty of dental sciences, IMS, BHU,Varanasi |
| Address |
Department of Periodontics,3rd Floor, Room no 5, Faculty of Dental Sciences IMS, BHU, Varanasi.
Department of Periodontics,3rd Floor, Room no 5, Faculty of Dental Sciences IMS, BHU, Varanasi.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7376080315 |
| Fax |
|
| Email |
anjalipatel3713@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Anjali Devi Patel |
| Address |
Department of Periodontics,3rd Floor, Room no 5, Faculty of Dental Sciences IMS, BHU, Varanasi, pin code 221005 |
| 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 |
| Dr Anjali Devi Patel |
Faculty of dental science, IMS, BHU |
room no 5, 3rd floor, unit of periodontology, faculty of dental sciences, Trauma centre BHU Varanasi, Uttar Pradesh, pin code 221005
Varanasi
UTTAR PRADESH |
07376080315
anjalipatel3713@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Banaras Hindu University Institute of Medical Sciences Institutional Ethics Committee Varanasi 221005 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
I.: Injectable Platelet Rich Fibrin (i-PRF)
II. Autologous Fibrin Glue (AFG)
III. Hyaluronic Acid (HA) Gel |
I.i-PRF prepared from autologous blood using low-speed centrifugation will be injected into the interdental papilla using a fine-gauge syringe. A single application will be performed at baseline, followed by clinical evaluation during the 3–6 month follow-up.
II.AFG prepared from the patient’s own blood will be applied topically into the interdental papillary region. One-time application will be done at baseline, and healing outcomes will be assessed during follow-up
III.0.2% HA gel will be applied locally in the interdental papilla once a week for 3 consecutive weeks. The site will be evaluated clinically over a 3–6 month follow-up period |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged between 18 to 55 years
2.Presence of interdental papillary loss in the maxillary anterior region
3.Good general health with no systemic conditions affecting periodontal healing
4.Willingness to participate and provide written informed consent
5.Presence of plaque index and gingival index scores within acceptable range
|
|
| ExclusionCriteria |
| Details |
1. Open contacts between the affected teeth.
2. Missing anterior teeth.
3. Smokers
4. Pregnant or breastfeeding females
5. Patients with systemic diseases.
6. Diastema
7. Patients with poor oral hygiene
8. Patients who take any medications known to cause gingival enlargement, gingival fillers previously done, teeth with caries, proximal restorations, fixed or orthodontic appliances.
9. Patients who had a periodontal surgeries six months prior to selection.
10. Severe periodontal bone loss.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effectiveness and outcome of injectable platelet rich fibrin versus autologous fibrin glue versus hyaluronic acid gel in the treatment of maxillary and mandibular interdental papillary deficiencies both clinically and photographically. |
To evaluate and compare the effectiveness and outcome of injectable platelet rich fibrin versus autologous fibrin glue versus hyaluronic acid gel in the treatment of maxillary and mandibular interdental papillary deficiencies both clinically and photographically at the base line ,1 week, 1 month,3 month, 6.month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To evaluate the effectiveness and clinical outcome of the injectable -platelet rich fibrin injection in treatment of maxillary and mandibular interdental papillary deficiency.
• To evaluate the effectiveness and clinical outcome of the autologous fibrin glue injection in treatment of maxillary and mandibular interdental papillary deficiency.
• To evaluate the effectiveness and clinical outcome of the hyaluronic acid gel injection in the treatment of maxillary and mandibular interdental papillary deficiency.
• To photographically evaluate and compare the improvement in black space in the interdental area followed by local injection of Injectable Platelet Rich Fibrin and Autologous fibrin glue, Hyaluronic acid gel using image J software
|
base line ,1 week , 1 month , 3month,6 month. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
02/08/2025 |
| 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 - NO
|
|
Brief Summary
|
This thesis presents a randomized clinical trial evaluating the effectiveness of injectable platelet-rich fibrin (i-PRF), autologous fibrin glue (AFG), and hyaluronic acid gel in reconstructing interdental papilla—the gum tissue between teeth. The study aims to compare these three biomaterials in terms of tissue regeneration, healing time, aesthetic outcomes, and patient comfort. Subjects with papilla loss received one of the treatments, and their progress was tracked over time. Results suggest that while all three approaches contributed to papilla reconstruction, i-PRF and AFG offered faster healing, and HA gel provided a minimally invasive option with promising cosmetic results. |