| CTRI Number |
CTRI/2024/05/066717 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical study to evaluate the efficacy of two different types of blood products in the gum enhancement around implant as well as in the acceleration of healing process in partial tooth loss patients. |
|
Scientific Title of Study
|
Clinical Evaluation of Peri-implant mucosal enhancement using L-PRF Vs T-PRF under Sohn’s poncho technique: 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 Thota Saranya |
| Designation |
Postgraduate Student |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7036356905 |
| Fax |
|
| Email |
saranyatrendt11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor and HOD |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor and HOD |
| Affiliation |
Vishnu Dental College |
| Address |
Block 2, Room 7,Department of Periodontics ,Vishnu Dental College, Vishnupur ,Bhimavaram
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur , Bhimavaram-534202, West Godavari District |
|
|
Primary Sponsor
|
| Name |
Dr Thota Saranya |
| Address |
Block 2, Room No 7, Department Of Periodontics, Vishnu Dental College Vishnupur, Bhimavaram |
| 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 Thota Saranya |
Vishnu Dental College |
Block 2 Room No 7 Department Of Periodontics, Vishnu Dental College Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH |
7036356905
saranyatrendy11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vishnu Dental College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Healing Abutment placement along with L-PRF |
Conventional Implant placement will be done in the mandibular posterior region with cover screw placement.After 3 months, patients will be recalled for second stage of implant surgery. Healing Abutment placement will be done along with L-PRF by collecting 10ml of venous blood from the patient by venepuncture into a sterile test tube and processing with a Centrifugation speed of 2700rpm and Centrifugation time of 12min Healing abutment placement along with L-PRF will be done and sutures will be placed. The total duration of the intervention is for 35-50min
Clinical evaluation of peri-implant mucosal thickness, width of keratinised mucosa will be done at baseline, 30 days and 45 days. Wound Healing Index will be assessed at 2 weeks. |
| Intervention |
Healing Abutment placement along with T-PRF |
Conventional Implant placement will be done in the mandibular posterior region with cover screw placement.After 3 months, patients will be recalled for second stage of implant surgery. Healing Abutment placement will be done along with T-PRF by collecting 10ml of venous blood from the patient by venepuncture into a sterile test tube by processing with a Centrifugation speed of 3500rpm and Centrifugation time of 15min Healing abutment placement along with T-PRF will be done and sutures will be placed. The total duration of the intervention is for 30-45min. Clinical evaluation of peri-implant mucosal thickness, width of keratinised mucosa will be done at baseline, 30 days and 45 days. Wound Healing Index will be assessed at 2 weeks.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who necessitated implant placement in mandibular posterior region
2.Patients with less than 2mm of peri implant mucosa
|
|
| ExclusionCriteria |
| Details |
1.Patients with uncontrolled systemic diseases
2. Pregnancy or lactating women
3. Chronic smokers
4. Patients with infectious diseases (HIV, Hepatitis B or Hepatitis C)
5. Patients undergoing radiation therapy
6. Patients under bisphosphonate therapy
7.Patients under antibiotic therapy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Peri-implant mucosal thickness |
Peri-implant mucosal thickness will be assessed at baseline, 30 days and 45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Width of Keratinized mucosa
2.Peri-implant mucosal healing
|
Width of Keratinized mucosa will be assessed at baseline, 30 days and 45 days
Peri-implant mucosal healing will be assessed at 2 weeks
|
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2024 |
| Date of Study Completion (India) |
22/01/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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 study evaluates the efficacy of L-PRF and T-PRF in peri-implant mucosal enhancement as well as in the acceleration of healing process using Sohn’s poncho technique.In one group, conventional implant placement will be done in the mandibular posterior region with cover screw placement. After 3 months, patients will be recalled for second stage and healing abutment will be placed using L-PRF. In other group, conventional implant placement will be done in the mandibular posterior region with cover screw placement. After 3 months, patients will be recalled for second stage and healing abutment will be placed using T-PRF.Clinical evaluation of peri-implant mucosal thickness, width of keratinised mucosa will be done at baseline, 30 days and 45 days. Wound healing index will be assessed at 2 weeks. |