| CTRI Number |
CTRI/2024/03/063892 [Registered on: 08/03/2024] Trial Registered Prospectively |
| Last Modified On: |
08/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
to evaluate how is the alveolar hone preserved when biodegradable collagen plug is placed in extracted sockets of orthodontic teeth |
|
Scientific Title of Study
|
Alveolar bone preservation of post orthodontic extraction socket using biodegradable Collagen Plug – A split – mouth clinico – radiographic study |
| 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 Damini Goel |
| Designation |
PG. Department of Oral and Maxillofacial surgery |
| Affiliation |
Dr.DY Patil Dental College and Hospital |
| Address |
Room no 9 , department of oral and maxillofacial surgery ,Dr.DY Patil Dental College and Hospital,Dr. DYPatil Vidyapeeth, Sant Tukaram Nagar, Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
7406180000 |
| Fax |
|
| Email |
dr.damini14@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushkar P Waknis |
| Designation |
MDS professor |
| Affiliation |
Dr.DY Patil Dental College and Hospital |
| Address |
Room no.9, Departrment of oral and maxillofacial surgery,Dr.DY Patil Dental College and Hospital,Dr. DYPatil Vidyapeeth, Sant Tukaram Nagar, Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9823047888 |
| Fax |
|
| Email |
pushkar.waknis@dpu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushkar P Waknis |
| Designation |
MDS professor |
| Affiliation |
Dr.DY Patil Dental College and Hospital |
| Address |
Room no.9, Department of Oral and maxillofacial surgery,Dr.DY Patil Dental College and Hospital,Dr. DYPatil Vidyapeeth, Sant Tukaram Nagar, Pimpri,Pune.
Pune
MAHARASHTRA
411018
India |
| Phone |
9823047888 |
| Fax |
|
| Email |
pushkar.waknis@dpu.edu.in |
|
|
Source of Monetary or Material Support
|
| Room no. 9, Department of Oral and maxillofacial surgery, Dr D Y Patil Dental College and Hospital D Y Patil Vidyapeeth Sant Tukaram Nagar Pune, Maharashtra, 411018 |
| Self, 84 Lotus enclave, pitampura , Delhi, 110034 |
|
|
Primary Sponsor
|
| Name |
Damini Goel |
| Address |
Room no 9 , department of oral and maxillofacial surgery, Dr.DY Patil Dental College and Hospital,Dr. DYPatil Vidyapeeth, Sant Tukaram Nagar, Pimpri,Pune.
Pune
MAHARASHTRA
411018
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 Damini Goel |
Dr DY Patil Dental College and Hospital |
Dept of Oral and maxillofacial Surgery room no.9,3rd floor,Pune
Pune
MAHARASHTRA |
7406180000
dr.damini14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub Committee, Dr D.Y. Patil Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Without Zimmer collagen plug |
other side- first premolar socket will be kept without collagen plug (empty) and socket will be evaluated after 6 weeks and 3 months |
| Intervention |
Zimmer Collagen Plug
(10mmx 20mm) |
ZIMMER Collagen plug (resorbable) will be inserted randomly into one maxillary and one mandibular premolar socket and socket will be evaluated after 6 weeks and 3 months. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients indicated for orthodontic extraction of premolar teeth under local anaesthesia.
2.Patients willing to accept the treatment plan.
|
|
| ExclusionCriteria |
| Details |
1. Any patient refusing to accept the treatment plan.
2. Patients with history of systemic diseases like juvenile diabetes and bleeding disorders.
3. Patients undergone traumatic extraction.
|
|
|
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 |
| soft tissue healing and bone height and width of alveolar socket post extraction will be evaluated |
after 10th day postoperatively, 6 weeks and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| rate of canine retraction & positioning |
After 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
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 2 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="1"
Months="6"
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
|
The study aims to evaluate the effectiveness of utilizing a collagen plug in preserving the alveolar socket following atraumatic premolar extraction. Alveolar bone resorption and atrophy are common post-extraction issues, prompting the need for adjunctive techniques to limit these occurrences. Preserving alveolar bone is vital for maintaining dental arch integrity and supporting structures. By comparing outcomes with and without the collagen plug, the study seeks to determine if this intervention can reduce bone resorption and enhance socket preservation, ultimately improving post-extraction outcomes and patient care in dentistry. |