| CTRI Number |
CTRI/2025/01/078883 [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 Trial |
|
Public Title of Study
|
Comparing Two Treatments for Bone Loss in the Gums: FDBA vs. Adbone® BCP |
|
Scientific Title of Study
|
Comparative evaluation of Freeze Dried Bone Allograft FDBA and Biphasic Calcium Phosphate Adbone® BCP Alloplast in the treatment of human intrabony periodontal defects: A 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 |
Shubham Sharma |
| Designation |
PG Resident |
| Affiliation |
Subharti Dental college and Hospitals |
| Address |
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut - 250005, Uttar Pradesh, India Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9731895472 |
| Fax |
|
| Email |
dr.shubhamsharma2016@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin Tomar |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospitals |
| Address |
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut - 250005, Uttar Pradesh, India Meerut
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9760003695 |
| Fax |
|
| Email |
drnitintomar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin Tomar |
| Designation |
Professor |
| Affiliation |
Subharti Dental College and Hospitals |
| Address |
Room no. 2 Department of Periodontology Subharti dental college and hospital Swami Vivekananda Subharti University, NH58, Delhi Haridwar Bypass Road Meerut - 250005, Uttar Pradesh, India Meerut
Meerut
UTTAR PRADESH
250002
India |
| Phone |
9760003695 |
| Fax |
|
| Email |
drnitintomar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontology Subharti Dental College and Hospital Swami Vivekanand Subharti University NH58 Delhi Haridwar Bypass Road Meerut 250005 Uttar Pradesh India |
|
|
Primary Sponsor
|
| Name |
Shubham Sharma |
| Address |
Swami Vivekananda Subharti University Subharti Dental College and Hospital |
| Type of Sponsor |
Other [Self Funded] |
|
|
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 Shubham Sharma |
Subharti Dental College and Hospital |
Department of Periodontology Subharti Dental College and Hospital Swami Vivekanand Subharti University NH58 Delhi Haridwar Bypass Road Meerut 250005 Uttar Pradesh India
Meerut
UTTAR PRADESH |
9731895472
dr.shubhamsharma2016@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group A FDBA Group |
Ten patients with angular intrabony periodontal defect
Follow up for baseline 3 months and 6 months |
| Intervention |
Group B ADBONE®BCP Group |
Ten 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. Good level of oral hygiene
2. Subjects of either sex having generalised Chronic Periodontitis
3. Subjects who are systemically healthy with no contraindication
to periodontal surgery
4. Presence of PD 5mm in relation to with radiographic evidence
of angular bone loss
5. 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 or
after phase I therapy
5. Pregnant or lactating females
6. Subjects who have undergone any periodontal surgery in the
past 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate And Compare The Reduction In Probing Pocket Depth Of Intrabony Defects With Fdba And ADBONE® BCP |
Baseline And 3 Months And 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate And Compare Gain In Bone Fill Achieved By The above Modalities Using Pre And Post Rvg |
Baseline And 3 Months And 6 Months |
|
|
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 3 |
|
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
|
Summary Group A (FDBA Group):
A patient meeting the inclusion criteria from the Periodontology department was inducted into the study. After informed consent, Phase 1 therapy was completed, followed by re-evaluation and recording of Relative Attachment Level (RAL). - Surgical Protocol:
- Intra-oral asepsis using 0.2% chlorhexidine and extra-oral asepsis with povidone-iodine.
- Crevicular incision and reflection of a full-thickness mucoperiosteal flap, preserving interdental tissues.
- Degranulation and root planing confirmed the presence of an intra-bony defect (IBD).
- Freeze-Dried Bone Allograft (FDBA) was procured from the Tissue Bank at Tata Memorial Hospital, mixed with saline, placed, and condensed into the defect.
- Sutures were placed, and patients were recalled for suture removal after one week and for follow-up at 3 and 6 months.
Group B (ADBONE®BCP Group):
A similar protocol was followed for patients in this group, using ADBONE®BCP alloplast procured from iFIX (Kamal Encon Industries, Faridabad). - Surgical Protocol:
- Phase 1 therapy, RAL measurement, asepsis, and flap reflection were conducted as described.
- The defect was filled with ADBONE®BCP mixed with saline, followed by suturing.
- Patients were recalled after 1 week for suture removal and follow-ups at 3 and 6 months.
Postoperative Care for Both Groups: - Patients were prescribed oral hygiene instructions, antibiotics, and analgesics for 5 days.
- Oral hygiene instructions were reinforced during the 7-day recall visit.
Outcome Measurements:
Baseline, 3-month, and 6-month clinical and radiographic assessments were recorded for statistical analysis. Remaining cases for test and control groups were conducted following the same methodology for comparative evaluation. |