| CTRI Number |
CTRI/2023/01/049332 [Registered on: 31/01/2023] Trial Registered Prospectively |
| Last Modified On: |
25/01/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Success of packing xenograft and collagen membrane in upper front teeth extraction socket for preservation of bone width. |
|
Scientific Title of Study
|
Effectiveness of Socket Preservation Technique Using Xenograft with Collagen
Membrane in Maxillary Anterior Teeth Extraction Socket - A Randomized
Controlled Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanchi Kadbe |
| Designation |
PG Student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
| Address |
Yojraj Residency, Plot no. 68, N-2, CIDCO, Aurangabad.(MS)
Nagpur
MAHARASHTRA
431001
India |
| Phone |
9579651938 |
| Fax |
|
| Email |
sanchi.kadbe99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aishwarya Kadu |
| Designation |
Reader |
| Affiliation |
SDKS Dental College, Nagpur |
| Address |
Medical square, Nagpur (MS)
Nagpur
MAHARASHTRA
440003
India |
| Phone |
|
| Fax |
|
| Email |
aishwarya.kadu@sdk-dentalcollege.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Kadu |
| Designation |
Reader |
| Affiliation |
SDKS Dental College, Nagpur |
| Address |
Medical square, Nagpur (MS)
Dhule
MAHARASHTRA
440003
India |
| Phone |
|
| Fax |
|
| Email |
aishwarya.kadu@sdk-dentalcollege.edu.in |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Smruti Dental College and Hospital, Nagpur.
Department no. 101. |
|
|
Primary Sponsor
|
| Name |
Dr. Sanchi Kadbe |
| Address |
Yograj Residency,Plot no. 68, Flat no. A-1, N-2, CIDCO, Aurangabad (MS)- 431001 |
| 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 Sanchi Kadbe |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Department number: 101, first floor, Sangam road, Wannadongri, Hingna, Nagpur.
Nagpur
MAHARASHTRA |
9579651938
sanchi.kadbe99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Comittee BORS SDKS,Nagpur |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A- Socket preservation with xenograft and collagen membrane |
Socket preservation with porcine xenograft and collagen membrane after atraumatic extraction. CBCT pre-operative and 4th month post-operative. |
| Comparator Agent |
Group B- Extraction without grafting |
Teeth will be extracted atraumatically and grafting will not be done. CBCT will be taken post-operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients who will be advised extraction in maxillary anterior region.
2.Patients who will give their consent for the study.
|
|
| ExclusionCriteria |
| Details |
1.Patients having uncontrolled systemic conditions.
2.Patients having generalised periodontitis where the gingival margin is
apical to CEJ.
3.Patients who are smokers or have any drug addiction.
4.Non-compliant patients or the patients who will not be abide to study
protocol. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Labiopalatal dimension
|
4th month post operative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Bone Density
Soft tissue healing |
Immediate post operative.
8th day post operative.
4th month post operative.
|
|
|
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)
|
06/02/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Primary Research Question: Is xenograft with collagen membrane effective in socket preservation in maxillary anterior teeth extraction socket? Objectives: 1. To evaluate and compare the bone density of maxillary anterior extracted socket with or without xenograft and collagen membrane. 2. To evaluate and compare the labio-palatal dimension of maxillary anterior extraction socket with or without xenograft and collagen membrane. 3. To evaluate and compare the soft tissue healing of maxillary anterior extraction socket with or without xenograft and collagen membrane.
|