| CTRI Number |
CTRI/2024/04/065752 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
22/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Two types of membranes prepared from patient blood in rebuilding the gaps between the teeth |
|
Scientific Title of Study
|
Clinical Evaluation Of Advanced Versus Titanium Reinforced Platelet Rich Fibrin In Interdental Papilla Reconstruction |
| Trial Acronym |
NILL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bandaru Shanmukha Rao |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Room no 7,Block 2, Department of Periodontics, Vishnu Dental college, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8897755990 |
| Fax |
|
| Email |
drshan225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Kumar |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Room no 7,Block 2, Department of Periodontics, Vishnu Dental college, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor and Head of the Department |
| Affiliation |
Vishnu Dental College |
| Address |
Room no 7,Block 2, Department of Periodontics, Vishnu Dental college, Bhimavaram.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College,Vishnupur,Bhimavaram Pin-534202 West Godavari Andhra Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Bandaru Shanmukha rao |
| Address |
Department of periodontics, block-2, room no-7, Vishnu Dental College Vishnupur, Bhimavaram, West Godavari ANDHRA PRADESH 534202 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 |
| Dr Bandaru Shanmukha Rao |
Vishnu Dental College |
Room no 7, Department of periodontics, Block 2, Vishnu Dental College, Vishnupur, Bhimavaram, Andhra pradesh
West Godavari
ANDHRA PRADESH
West Godavari
ANDHRA PRADESH |
8897755990
drshan225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Vishnu dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K060||Gingival recession, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Advanced Platelet Rich Fibrin |
10 ml of Blood Will be Collected from the patient in A PRF Tubes and Processed to Form A-PRF. That Will Be Placed in the Pouch that is Created in Patient by giving semilunar incision beneath the deficient papilla Under Surgical Operating Microscope. Clinical Evaluation will be done at 0 Day,3 Months, and 6 Months. |
| Intervention |
Titanium Reinforced Platelet Rich Fibrin. |
10 ml of Blood Will be Collected from the patient in Titanium Tubes and Processed to Form A-PRF. That Will Be Placed in the Pouch that is Created in Patient by giving semilunar incision beneath the deficient papilla Under Surgical Operating Microscope. Clinical Evaluation will be done at 0 Day,3 Months, and 6 Months. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients With Class 1 and 2 papillary loss in Maxillary anterior.
2.Keratinized Tissue Around the Teeth greater than 2mm.
3.Non smoker Patients. |
|
| ExclusionCriteria |
| Details |
1. Patients With Uncontrolled Systemic Diseases
2. Pregnant or Lactating Women,
3. Chronic Smokers, Patients with Systematic Diseases,
4. Patients under Anticoagulant Therapy, Platelet Coun0t Less Than One Lakh Cells Per Cubic mm,
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 Black Triangle height.
2 Black Triangle width
3 Percentage Fill
4 Patient satisfaction Response- Visual analogue score (VAS)
5 Pink Esthetic Scores.
|
1.Black Triangle height At Baseline 3 Months 6 Months
2. Black Triangle width At Baseline 3 Months 6 Months
3. Percentage Fill At Baseline
3 Months 6 Months
4. Patient satisfaction Response- Visual analogue score (VAS)
5. Pink Esthetic Scores At Baseline 3 Months 6 Months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Probing Depths
2. Clinical Attachment Level.
3. Plaque Index
4. Gingival Index
5. Patient satisfaction Response- Visual analogue score (VAS)
6. Pink Esthetic Scores. |
1. Probing Depths At Baseline 3 Months 6 Months
2. Clinical Attachment Level At Baseline 3 Months 6 Months.
3. Plaque Index At Baseline 3 Months 6 Months
4. Gingival Index At Baseline 3 Months 6 Months
5. Patient satisfaction Response- Visual analogue score (VAS) at baseline,3months and 6 months
6. Pink Esthetic Scores At Baseline 3 Months 6 Months.
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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)
|
24/04/2024 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
The Aim of the Study is to Assess the Therapeutic Efficacy of A-PRF and T-PRF in Improving the Interdental Papilla in Aesthetic Zones. A Total of 20 Patients With Norland and Tarnow Class 1 and II papillary Will be Selected from the Out Patient Department of Periodontology, Vishnu Dental College Will be Divided into 2 gropus,10 in each group. A-PRF Will be Placed in Control Group and T-PRF will be Placed in Interventional group by Creating Pouch using Semilunar Incison Under surgical Operating Microscope . Computer generated randomization will be used as sampling method. In Both the groups Parameters such as papillary fill,gingival plaque index will be evaluated at Base line 3 Months and 6 Months. |