| CTRI Number |
CTRI/2025/01/078950 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| 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 Freeze Dried Bone Allograft And Tioss In Human Periodontal Intabony Defect |
|
Scientific Title of Study
|
Comparitive Evaluation Of Freeze Dried Bone Allograft (Fdba) Versus Octacalcium Phosphate Coated Deproteinized Bovine Bone Material (Tioss) Xenograft In The Treatment Of Human Intabony Periodontal Defects - A Clinico-Radiographic Study |
| Trial Acronym |
NO |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Priyanshu Ramuka |
| Designation |
Post Graduation |
| Affiliation |
Subharti University |
| Address |
Room no. 2 Department Of Periodontology Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road, Meerut
Bank enclave 197 delhi
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7023754951 |
| Fax |
|
| Email |
ramuka.priyanshu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sameer Ahmed |
| Designation |
Assistant Professor |
| Affiliation |
Subharti University |
| Address |
Room no. 2 Department Of Periodontology Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road, Meerut
Room no. 2Department Of Periodontology Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9928634117 |
| Fax |
|
| Email |
Sameer82ahmed@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyanshu Ramuka |
| Designation |
Post Graduation |
| Affiliation |
Subharti University |
| Address |
Room no. 2 Department Of Periodontology Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7023754951 |
| Fax |
|
| Email |
ramuka.priyanshu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti dental college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Priyanshu Ramuka |
| Address |
Room no. 2 Department Of Periodontology Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypss Road, Meerut |
| Type of Sponsor |
Other [Subharti Dental College] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Sameer Ahmed |
Room no. 2 Department Of Periodontology Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypss Road, Meerut |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Priyanshu Ramuka |
Subharti Dental College |
Room no.2, Department of periodontology and implantology, Ground floor, Swami Vivekanand Subharti University, Subharti Dental College,Subhartipuram, NH-58 Delhi Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH |
702354951
ramuka.priyanshu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A FDBA GROUP |
PATIENTS WITH ANGULAR INTRABONY PERIODONTAL DEFECTS FOLLOW UP FOR BASELINE 3 MONTHS AND 6 MONTHS |
| Intervention |
GROUP B TIOSS GROUP |
PATIENTS WITH ANGULAR INTRABONY PERIODONTAL DEFECT FOLLOW UP FOR BASELINE 3 MONTHS AND 6 MONTHS |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Age group ranging from 25-50 years.
2)Good level of oral hygiene.
3)Subjects of either sex.
4)Subjects who are systemically healthy with no
contraindication to periodontal surgery.
5)Presence of PPD ≥ 5mm with radiographic evidence
of angular bone loss.
6)Compliant subjects.
|
|
| ExclusionCriteria |
| Details |
1)Subjects with any systemic disease.
2)Individuals having any deleterious habits, such
as smoking or tobacco chewing.
3)Subjects allergic or sensitive to any medication
or any ingredient of the test- material.
4)Subjects showing unacceptable oral hygiene
compliance during/ after phase-I therapy.
5)Pregnant or lactating females
6)Subjects who have undergone any periodontal
surgery in the past 6 months.
7)Subjects taking
steroids/chemotherapy/Radiotherapy.
8)Non co-operative subjects.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction In Probing Pocket Depth |
Baseline 3 Month 6 Month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluate And Compare Gain In Bone Fill Achieved |
Baseline 3 Month 6 Month |
|
|
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 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="2"
Months="0"
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
|
Under local anesthesia, crevicular incision was given and a full thickness mucoperiosteal flap was reflected and all the precautions were taken to preserve interdental tissues to the maximum. In group 1 the area was degranulated meticulously and root planning was done using area specific curette and the presence of Intrabony bony defect was measured using UNC15 . After isolation, FDBA was placed in the defect and condensed in the defect site. Sutures were placed and patient was recalled after 1 week for suture removal .In group 2 TI-OSS bone graft was condensed at the defect site and then resorbable sutures were placed. Subsequent Follow up of the defect site will be carried out at 3 and 6 months for both groups. |