| CTRI Number |
CTRI/2024/11/076355 [Registered on: 07/11/2024] Trial Registered Prospectively |
| Last Modified On: |
06/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing the Effects of Amnion Chorion Membrane and Collagen Membrane with Bone Graft in Treating Tooth Bone Defects: A Clinical Study |
|
Scientific Title of Study
|
A Comparative evaluation of the efficacy of amnion chorion membrane and collagen membrane with demineralized bone graft in intrabony defects-a split mouth randomized 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 |
Pendyala Neelima |
| Designation |
Post graduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room number -10,Department of Periodontics,GSL Dental College,
Rajanagaram,
Rajahmundry, Andhra Pradesh,India
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
09542633929 |
| Fax |
|
| Email |
neelimapendyala456@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Anupama Masapu |
| Designation |
Proffessor & Head of the department |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room number -10,Department of Periodontics,GSL Dental College,Rajanagaram,
Rajahmundry,Andhra Pradesh , India
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
|
| Fax |
|
| Email |
anu3267@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Pendyala Neelima |
| Designation |
Post Graduate |
| Affiliation |
GSL Dental College and Hospital |
| Address |
Room number -10,Department of Periodontics,GSL Dental College,Rajanagaram,
Rajahmundry,Andhra Pradesh , India
East Godavari
ANDHRA PRADESH
533296
India |
| Phone |
09542633929 |
| Fax |
|
| Email |
neelimapendyala456@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room number -10,Department of Periodontics,GSL Dental College,Rajanagaram,
Rajahmundry,Andhra Pradesh , India,533296 |
|
|
Primary Sponsor
|
| Name |
Pendyala Neelima |
| Address |
Room number -10,Department of Periodontics,GSL Dental College,Rajanagaram,
Rajahmundry,Andhra Pradesh , India,533296 |
| 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 Pendyala Neelima |
GSL Dental College and Hospital |
Room no-10,
Department of Periodontics,
GSL DentalC ollege and Hospital,
Rajanagaram,
Rajahmundry
East Godavari
ANDHRA PRADESH |
9542633929
neelimapendyala456@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GSL Dental College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A488||Other specified bacterial diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amnion chorion membrane |
12 sites will be selected based on inclusion criteria and after open flap debridement Amnion chorion membrane will be placed along with bone graft and flap will be secured with sutures |
| Comparator Agent |
Collagen membrane |
12 sites will be selected based on inclusion criteria and after open flap debridement Collagen membrane will be placed along with bone graft and flap will be secured with sutures. |
|
|
Inclusion Criteria
|
| Age From |
32.00 Year(s) |
| Age To |
49.00 Year(s) |
| Gender |
Both |
| Details |
Age group between 32 to 49 years in both genders
Systemically healthy patients
Diagnosed with generalized chronic periodontitis
Evidence of intrabony defects
Pocket depth greater than 5mm |
|
| ExclusionCriteria |
| Details |
Pregnant or lactating women
Patients taking any medication 3 months prior to the study
Receiving any periodontal treatment 6 months prior to study initiation.
Former or Current smokers. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival Index, Periodontal Pocket Depth, Clinical Attachment Level. |
baseline,3months and 6months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bone fill |
baseline and 6months
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2024 |
| 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="8"
Days="8" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
A Split mouth Randomized clinical trial will be conducted. A total number of 24 sites will be chosen. Patients will be selected based on inclusion criteria.12 sites each will be randomly allocated to test (Amnion Chorion Membrane)and control (Collagen Membrane) groups. Demineralized bone matrix will be placed for the both groups. Patients will be recalled after 3 months and 6 months post operatively for recording clinical and radiographic parameters. Clinical parameters include Plaque index(PI), Gingival Index(GI), Periodontal Pocket Depth(PPD), Clinical Attachment Level(CAL). Radiographic parameters including BDA (Bone Defect Area), from CEJ to bottom of the IBD(Intra Bony Defect),from CEJ to Alveolar Crest ,from Alveolar Crest to base of IBD is measured using CBCT. |