| CTRI Number |
CTRI/2024/12/078666 [Registered on: 27/12/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Implant with membrane for better bone formation |
|
Scientific Title of Study
|
Comparative evaluation of A-prf+ or collagen membrane on hard and soft tissue changes following immediate implant placement- A randomised 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 Raagul S |
| Designation |
PG STUDENT |
| Affiliation |
ITS CDSR |
| Address |
Department of periodontology and oral implantology, Room no.05, ITS centre for dental studies and research, NH-34 delhi-meerut road, Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
07397188390 |
| Fax |
|
| Email |
raagul49@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Rahul Chopra |
| Designation |
PROFESSOR |
| Affiliation |
ITS CDSR |
| Address |
Department of periodontology and oral implantology, Room no.05, ITS centre for dental studies and research, NH-34 delhi-meerut road, Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
9953865327 |
| Fax |
|
| Email |
dr.rahulchopra@its.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raagul S |
| Designation |
PG STUDENT |
| Affiliation |
ITS CDSR |
| Address |
Department of periodontology and oral implantology, Room no.05, ITS centre for dental studies and research, NH-34 delhi-meerut road, Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH
201206
India |
| Phone |
07397188390 |
| Fax |
|
| Email |
raagul49@gmail.com |
|
|
Source of Monetary or Material Support
|
| ITS centre for dental studies and research, NH-34 delhi-meerut road, Muradnagar, Ghaziabad Utter pradesh- 201206 |
|
|
Primary Sponsor
|
| Name |
Dr Raagul S |
| Address |
Department of periodontology and oral implantology, Room no.05, ITS centre for dental studies and research, NH-34 delhi-meerut road, Muradnagar, Ghaziabad |
| 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 Raagul S |
ITS Center for Dental Studies and Research |
Department of periodontology and oral implantology, Room no.05, NH-34 delhi-meerut road, Muradnagar, Ghaziabad
Ghaziabad
UTTAR PRADESH |
07397188390
raagul49@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| I.T.S institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Clinically Non restorable teeth |
| Patients |
(1) ICD-10 Condition: K039||Disease of hard tissues of teeth,unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
A-Prf+ |
Around 5 ml of whole venous blood was collected in two sterile vacutainer tubes each of 6 ml capacity without anticoagulant. The vacutainer tubes were then placed in a centrifugal machine at 1300 revolutions per minute (rpm) for 8 minutes. Following this the centrifuged blood settled into the following layers: red lower fraction containing red blood cells, upper straw-coloured cellular plasma and the middle fraction containing the fibrin clot. The upper straw-coloured layer was removed and middle fraction was collected, 2 mm below the lower dividing line, which was the A-PRF+. Membrane was then prepared from it by squeezing it between two plates of the PRF box. ï¬APRF+ will be placed to augment soft tissue at the implant site. Membrane extends 2-3mm under the buccal and lingual aspect of the alveolar ridge and secured back with the help of 4-0 horizontal mattress sutures. |
| Intervention |
COLLAGEN MEMBRANE |
Collagen membrane will be placed to augment soft tissue at the implant site. Membrane extends 2-3mm under the buccal and lingual aspect of the alveolar ridge and secured back with the help of 4-0 horizontal mattress sutures. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Subjects aged between 18- 60 years.
2. Patient with adequate oral hygiene status.
3. No active periodontal disease.
4. Patients requiring the replacement of one or more non-restorable teeth with sufficient bone volume will be selected for the study.
5. Patient willing to give informed consent.
6. Patients with good compliance so as to meet the follow-up. |
|
| ExclusionCriteria |
| Details |
1. Patient with systemic disease.
2. Patient with autoimmune disease, psychiatric disorder , osteoporosis.
3. Patient undergoing or who underwent radiation therapy and chemotherapy to the head and neck region during the last 12 months.
4. Patient with poor oral hygiene.
5. Alcoholics , drug abusers or heavy smokers.
6. Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. SOFT TISSUE THICKNESS
Midbuccal and Midlingual/Midpalatal soft tissue thickness will be measured 3mm from the gingival crest margin using endodontic K-File with stopper. Standardization achieved using indented acrylic stent. The soft tissue thickness on endodontic K-file will be measured using digital vernier caliper.
2. WIDTH OF KERATINIZED TISSUE
will be measured using UNC 15 periodontal probe, using a standardized acrylic stent.
3. RADIOGRAPHIC PARAMETERS
Crestal bone levels will be measured with CBCT using acrylic stent with gutta percha point for standardization before implant placement (baseline) and after 3 months postoperatively. |
Baseline to 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Implant Stability Quotient (ISQ) :
ISQ will be measured using RFA (Penguin®) immediately after implant placement and at 3 months after implant placement.
2. PLAQUE INDEX (Turskey – Gilmore - Glickman modification of Quigely - Hein Plaque index in 1970)
3. GINGIVAL INDEX (Loe and Silness in 1963) |
Baseline to 3 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
|
Phase 4 |
|
Date of First Enrollment (India)
|
30/12/2024 |
| 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="0"
Months="5"
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
|
AIM :The aim of this present study is to compare the clinical efficacy of A-PRF+ and collagen membrane after immediate implant placement and to evaluate the hard and soft tissue changes around the implant site. OBJECTIVES :To evaluate and compare clinical parameters viz. Gingival Index(GI), Plaque Index(PI), Width of Keratinized Tissue(WKT), Midbuccal & Midlingual/Midpalatal soft tissue thickness and ISQ values at baseline and 3 months in Group I (Immediate implant placement & A-PRF+) and Group II (Immediate implant placement & Collagen Membrane). To evaluate and compare crestal bone levels using CBCT at baseline and 3 months in Group I (Immediate implant placement & A-PRF+) and Group II (Immediate implant placement & Collagen Membrane). Immediate implant is a highly reliable option for replacement for teeth as it shortens the overall treatment time and also preserves the bone architecture. Following immediate implant placement there will be some amount of bone loss owing to remodeling. So, using biomaterials like A-PRF+ and collagen membrane during IIP may be helpful in decreasing the bone resorption around the implant. A-PRF+ and collagen membrane may also enhances the soft tissue volume around the implant. A-PRF+ being autologous product may be preferred over xenogenic collagen membrane if results are in favour of A-PRF+. |