| CTRI Number |
CTRI/2021/07/034897 [Registered on: 15/07/2021] Trial Registered Prospectively |
| Last Modified On: |
09/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Medical Device
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluation of gum health around implants( metal screw placed in bone) placed with a cell layer made from blood compared with no cell layer placement in a single patient on both sides of jaw. |
|
Scientific Title of Study
|
Evaluation of Peri-implant mucosal thickness using L-PRF under Sohns Poncho technique during second stage - A split mouth, randomized clinical trial with a six week follow up |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor and Head of the Department |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
Room no 7 Department of Periodontics and Implantology, Block 2, Vishnu Dental college, Vishnupur, Bhimavaram
Room no 7 Department of Periodontics and Implantology, Block 2, Vishnu Dental college, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gautami S Penmetsa |
| Designation |
Professor and Head of the Department |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
Room no 7 Department of Periodontics and Implantology, Block 2, Vishnu Dental college, Vishnupur, Bhimavaram
Room no 7 Department of Periodontics and Implantology, Block 2, Vishnu Dental college, Vishnupur, Bhimavaram
ANDHRA PRADESH
534202
India |
| Phone |
9951011618 |
| Fax |
|
| Email |
gautamipenmetsa@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
B Bharghavi Patnaik |
| Designation |
Post Graduate |
| Affiliation |
VISHNU DENTAL COLLEGE |
| Address |
Room no 7 Department of Periodontics and Implantology, Block 2, Vishnu Dental college, Vishnupur, Bhimavaram
Room no 7 Department of Periodontics and Implantology, Block 2, Vishnu Dental college, Vishnupur, Bhimavaram
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8712311852 |
| Fax |
|
| Email |
bharghavipatnaik@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
B Bharghavi Patnaik |
| Address |
Room no. 7
Department of Periodontics and Implantology
Block 2
Vishnu Dental College
Bhimavaram |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Gautami S Penmetsa |
Room no. 7
Department of Periodontics and Implantology
Block 2
Vishnu Dental College
Bhimavaram |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| B Bharghavi Patnaik |
Vishnu Dental College |
Room no 7
Department of Periodontics and Implantology
Block 2 Vishnu Dental College
Bhimavaram
West Godavari
ANDHRA PRADESH |
8712311852
bharghavipatnaik@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE VISHNU DENTAL COLLEGE BHIMAVARAM |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge, (2) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
L PRF membrane placement during healing abutment placement |
Membrane is prepared from centrifugation of patients own blood for 12 minutes at 2700rpm |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients who require an implant in mandibular posterior region bilaterally
Patients with a minimum of 2 to 3 mm of peri implant mucosa
|
|
| ExclusionCriteria |
| Details |
Smokers
Uncontrolled diabetes
Severe cardiovascular problems
Pregnant or lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Wachtel’s early healing index
Peri implant mucosal thickness Width of keratinized mucosa |
baseline
7 days
14 days
6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
15/07/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not Initiated |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Patients who require implants in bilaterally edentulous mandibular back teeth region will be included in the study and implant placement will be done. After the implant is placed patient will be called after 3 months. At the time of second appointment one side a membrane which will be obtained from the patients blood will be placed during healing abutment placement and only healing abutment will be placed on the other side. Soft tissue thickness, healing and width of keratinized mucosa will be compared in two groups. |