| CTRI Number |
CTRI/2024/11/076803 [Registered on: 14/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different techniques for interdental papilla regeneration |
|
Scientific Title of Study
|
Comparative Evaluation of clinical effectiveness of titanium-prepared platelet-rich fibrin and connective tissue graft in papilla reconstruction |
| 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 Amrutha Rao |
| Designation |
Postgraduate student |
| Affiliation |
MS Ramaiah Dental College |
| Address |
Room no. 2, Department of Periodontology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, MSR Nagar, Mathikere, Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
7219439190 |
| Fax |
|
| Email |
amrutharao9588@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhavya Shetty |
| Designation |
Associate Professor |
| Affiliation |
MS Ramaiah Dental College |
| Address |
Room no.2, Department of Periodontology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, MSR Nagar,Mathikere,Bangalore
Bangalore
KARNATAKA
560054
India |
| Phone |
9880262593 |
| Fax |
|
| Email |
bhavyashetty123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrutha Rao |
| Designation |
Postgraduate student |
| Affiliation |
MS Ramaiah Dental College |
| Address |
Room no.2, Department of Periodontology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, MSR Nagar, Mathikere, Bangalore
KARNATAKA
560054
India |
| Phone |
7219439190 |
| Fax |
|
| Email |
amrutharao9588@gmail.com |
|
|
Source of Monetary or Material Support
|
| Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Amrutha Rao |
| Address |
Room No.2, Department of Periodontology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, MSR Nagar, Mathikere, Bangalore, Karnataka-560054 |
| Type of Sponsor |
Other [Self funded] |
|
|
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 Amrutha Rao |
Faculty of Dental Sciences, Ramaiah University of Applied Sciences |
Room No.2, Department of Periodontology, Faculty of Dental Sciences, Ramaiah University of Applied Sciences, MSR Nagar, Mathikere, Bangalore
Bangalore
KARNATAKA |
7219439190
amrutharao9588@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MS RAMAIAH UNIVERSITY OF APPLIED SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K056||Periodontal disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Connective Tissue Graft |
Interdental Papilla Reconstruction using Connective Tissue Graft via Tunneling Technique
0 visit: Patient Recruitment
1 visit: Treatment after 2 weeks
2 visit: Follow-up at 1 month
3 visit: Follow-up at 3 months |
| Intervention |
T PRF |
Interdental Papilla Reconstruction with T PRF Via Tunneling Technique
0 visit: Patient Recruitment
1 visit: Treatment after 2 weeks
2 visit: Follow-up at 1 month
3 visit: Follow-up at 3 months |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Teeth having contact points
At least 2 mm keratinized tissue width (KTW)
Probing depth (PD) ≤3 mm adjacent to the
open embrasure
|
|
| ExclusionCriteria |
| Details |
Patients with cardiovascular disease, type
2 diabetes mellitus, or osteoporosis
Patients having anti-epileptics,
immunosuppressants, corticosteroids, non-
steroidal anti-inflammatory drugs or
hormones
Patients using tobacco/alcohol
Pregnant and lactating women
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PAPILLA HEIGHT |
BASELINE, 1 MONTH, 3 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 |
|
Date of First Enrollment (India)
|
01/01/2025 |
| 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 Yet Recruiting |
| 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
|
Rationale:
Interdental
papilla morphology is determined by factors such as age, shape of crown,
contact position and angle between the roots of adjacent teeth, alveolar
crest-interdental contact point distance, interdental embrasure volume, crestal
bone height, soft tissue appearance, periodontal disease and history of
periodontal surgery. Interdental papilla loss which leads to appearance of
black triangles between teeth can cause aesthetic disorders, phonetic problems,
and food accumulation (Chow et al, 2010, Sharma et al, 2010; Tarnow, 1992).
Though various non-surgical approaches through prosthetic,
restorative, and orthodontic procedures have been used for papilla
reconstruction, they have not always yielded satisfactory results. Several full
or partial thickness, free or pedicle tissue management surgical techniques
including roll, rotated, or advanced flaps have been proposed for papilla
reconstruction (Deepalakshmi, 2007; De Castro Pinto, 2010). Several studies
state that Connective tissue grafts provide better results than conventional Platelet
rich fibrin despite their disadvantages such as presence of a second wound site
and variable papilla reconstruction outcomes.
Tunali et al., in 2013 harnessed titanium biomedical tubes
for the construction of Titanium coated titanium platelet‑rich fibrin (T‑PRF).
Titanium has been more useful in stimulating platelets compared to glass tubes
and forms a thicker fibrin clot exhibiting longer resorption span and profuse
fibrin meshwork provoking increase cellularity at the prescribed loci thereby
inducing periodontal genesis (Tunali, 2014).
Need for the study:
With Titanium having one of the greatest bio-compatibility,
the application of titanium-prepared
platelet-rich fibrin involves minimally invasive technique with low risk
and satisfactory clinical outcomes, but limited research is done on titanium-prepared platelet-rich fibrin. To the
best of our knowledge, no studies are done to evaluate the success of titanium-prepared platelet-rich fibrin in papilla
reconstruction. |