| CTRI Number |
CTRI/2023/06/053851 [Registered on: 14/06/2023] Trial Registered Prospectively |
| Last Modified On: |
13/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
COMPARISON OF HARD AND SOFT TISSUE CHANGES OF EXTRACTION SOCKET PRESERVED WITH BONE GRAFT AND MEMBRANE VS. SPONTANEOUS HEALING OF THE SOCKET.
|
|
Scientific Title of Study
|
COMPARISON OF HARD AND SOFT TISSUE CHANGES OF SOCKET PRESERVED WITH INDIGENOUSLY PREPARED DEMINERALISED FREEZE DRIED BONE ALLOGRAFT(DFDBA) & AMNION CHORION MEMBRANE(ACM) VS. SPONTANEOUS HEALING OF THE SOCKET: A CLINICAL STUDY
|
| Trial Acronym |
COMPARISON OF SOCKET WITH AND WITHOUT GRAFT AND MEMBRANE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJESH SAHU |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY , MAULANA AZAD INSTITUTE OF DENTAL SCIENCES,ITO BAHADUR SHAH ZAFAR MARG
NEW DELHI 110002
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES ,ITO ,BAHADUR SHAH ZAFAR MARG NEW DELHI
South
DELHI
110002
India |
| Phone |
7011826669 |
| Fax |
|
| Email |
sahu9168448@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR ARUNDEEP KAUR |
| Designation |
PROFESSOR & HEAD OF DEPARTMENT |
| Affiliation |
DELHI UNIVERSITY |
| Address |
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY, MAULANA AZAD INSTITUTE OF DENTAL SCIENCES,ITO,BAJHADUR SHSH ZAFAR MARG NEW DELHI
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES ,ITO ,BAHADUR SHAH ZAFAR MARG NEW DELHI
South
DELHI
110002
India |
| Phone |
7011826669 |
| Fax |
|
| Email |
arundeep.kaur.lamba@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJESH SAHU |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES |
| Address |
DEPARTMENT OF PERIODONTICS ,MAULANA AZAD INSTITUTE OF DENTAL SCIENCES ITO
MAULANA AZAD INSTITUTE OF DENTAL SCIENCES ,ITO ,BAHADUR SHAH ZAFAR MARG NEW DELHI
South
DELHI
110044
India |
| Phone |
7011826669 |
| Fax |
|
| Email |
sahu9168448@gmail.com |
|
|
Source of Monetary or Material Support
|
| MAULANA AZAD INSTITUTE OF DENTAL SCIENCES ,ITO ,BAHADUR SHAH ZAFAR MARG,NEW DELHI 110002 |
|
|
Primary Sponsor
|
| Name |
Dr RAJESH SAHU |
| Address |
N-49 Harinagar extension near A.S public school ,JAITPUR BADARPUR NEW DELHI 110044 |
| 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 RAJESH SAHU |
Maulana azad institute of dental sciences |
DEPARTMENT OF PERIODONTICS AND ORAL IMPLANTOLOGY, FLOOR -6 Maulana azad institute of dental sciences, ito ,bahadur shah zafar marg new delhi 110002
New Delhi
DELHI |
7011826669
sahu9168448@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
pateint should not having any chronic medical condition that may affect the bone condition. |
| Patients |
(1) ICD-10 Condition: K049||Other and unspecified diseases ofpulp and periapical tissues, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INDIGENOUSLY PREPARED BONE GRAFT AND AMNION CHORION MEMBRANE |
AFTER ATRAUMATIC EXTRACTION OF TOOTH THE SOCKET IS PRESERVED WITH INDIGENOUSLY PREPARED BONE GRAFT AND AMNION CHORION MEMBRANE AT THE TIME OF EXTRACTION |
| Comparator Agent |
NONE |
AFTER ATRAUMATIC EXTRACTION OF TOOTH THE SOCKET IS ALLOWED TO HEAL SPONTANEOUSLY WITHOUT ANY GRAFT PLACEMENT |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects of either sex between the age group of 18-55 years, who are willing to sign informed consent form for the study.
2.Subjects in whom extraction is indicated in single rooted tooth in maxilla and /or mandible with intact adjacent teeth for stent fabrication and placement.
3.Clinical root length/residual socket depth should be >8 mm.
4.To select only sites where the tooth location and root angulation is consistent with the ideal implant orientation where inter-occlusal distance is adequate for a dental implant placement.
|
|
| ExclusionCriteria |
| Details |
Teeth adjacent to extraction socket having any periapical and/or active periodontal disease.
Pregnant women and/or expected pregnancy during the study period.
lactating women.
smokers smoking more than 10 cigarrete per day.
subjects under long term bisphosphponate therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
The horizontal bone resorption at the test sites expected to be 1.6 ± 0.55 mm less as compared to control group.
The vertical bone resorption at the test sites expected to be 1.1± 0.5 mm less as compared to test group.
The test sites expected to show a better preservation of width and thickness of keratinized tissue when compared to control sites. |
AT BASE LINE AND 6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The control sites are expected to require an additional bone augmentation at implant placement, when compared to the test sites.
Test sites are expected to allows the placement of longer and wider implants when compared to implants inserted in control sites .
|
AFTER A PERIOD OF 6 MONTHS. |
|
|
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)
|
25/06/2023 |
| 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="1"
Months="6"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
The AIM of my study is To evaluate the hard and soft tissue changes of extraction sockets with and without ridge preservation using indigenously prepared DFDBA &amnion chorion membrane (ACM). The study will comprise of 24 adult subjects of either sex with single rooted teeth having normal adjacent tooth on either side ,of either jaw, as defined in the inclusion criteria and agree to sign the informed consent.The subjects will be recruited from the Outpatient Department of Periodontics at Maulana Azad Institute of Dental Sciences. Test group- Socket preservation with DFDBA block graft and amnion chorion membrane. After atraumatic extraction of the tooth the socket will be preserved using DFDBA bone graft and Amnion-chorion membrane .The subjects will be recalled after a period of 6 months for evaluation of the hard and the soft tissue changes of the extraction socket and comparing it with unassisted healing of the socket.
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