| CTRI Number |
CTRI/2025/09/095104 [Registered on: 19/09/2025] Trial Registered Prospectively |
| Last Modified On: |
18/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry
Other (Specify) [Bone Graft] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study in patients with gum disease comparing two treatments to improve bone healing around teeth. |
|
Scientific Title of Study
|
Comparative Evaluation Of Demineralized Freeze-Dried Bone Allograft versus Biphasic Calcium Phosphate in Periodontal Intrabony Defects Using A Radiographic Grid With The Long Cone Paralleling Technique – A Randomised Controlled Study |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhumitha C |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental college and Hospital Mumbai |
| Address |
215 , Department of Periodontology, Government Dental College And Hospital, St George Hospital Campus, Near Csmt, Fort, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8072523286 |
| Fax |
|
| Email |
cm.maddy99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Gaikwad |
| Designation |
Professor ( Academic ) |
| Affiliation |
Government Dental college and Hospital Mumbai |
| Address |
215 , Department of Periodontology, Government Dental College And Hospital, St George Hospital Campus, Near Csmt, Fort, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
9821098772 |
| Fax |
|
| Email |
perioraja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhumitha C |
| Designation |
Postgraduate Student |
| Affiliation |
Government Dental college and Hospital Mumbai |
| Address |
215 , Department of Periodontology, Government Dental College And Hospital, St George Hospital Campus, Near Csmt, Fort, Mumbai
Mumbai
MAHARASHTRA
400001
India |
| Phone |
8072523286 |
| Fax |
|
| Email |
cm.maddy99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Dental college and Hospital Mumbai |
|
|
Primary Sponsor
|
| Name |
Dr Madhumitha C |
| Address |
215, Department of periodontology, Government Dental college and Hospital Mumbai, St Georges campus, PD Mello road, csmt fort, Mumbai - 400001 |
| Type of Sponsor |
Other [Self sponsered] |
|
|
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 Madhumitha C |
Government Dental college and Hospital, Mumbai215, |
215 , Department of Periodontology, Government Dental College And Hospital, St George Hospital Campus, Near Csmt, Fort, Mumbai
Mumbai
MAHARASHTRA |
8072523286
cm.maddy99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Dental College and Hospital, Mumbai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Biphasic calcium phosphate |
Placed in periodontal intrabony defects after flap surgery in patients having chronic periodontitis aged between 25 years to 55 years. and outcomes to be evaluated at 1 month, 3 months, and 6 months |
| Intervention |
Demineralized freeze dried bone allograft in intrabony defects |
Placed in periodontal intrabony defects after flap surgery in patients having chronic periodontitis aged between 25 years to 55 years. and outcomes to be evaluated at 1 month, 3 months, and 6 months |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.15 Patients aged between 25 and 55 years both Male and femalewith chronic periodontitis having intrabony defects( two-walled and three-walled defects )bilaterally in any quadrant.
2.Probing pocket depth (PPD) greater than or equal to 5 mmusing UNC-15 probe.
3.Clinical attachment loss ( CAL ) greater than or equal to3mm using UNC-15 probe.
4.Favorable intrabony defect radiographically greater than or equal to 3mm.
5.Grade I mobile tooth.
6.Patient willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Medically compromised patients having uncontrolled Diabetes and Hypertension.
2.Smokers and smokeless tobacco users
3.Pregnant women and lactating mothers
4.Grade II and III Mobile tooth
5.A patient who is unable to attend follow-up appointments.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing Pocket Depth, Clinical Attachment Level, radiographic defect fill and defect resolution |
1 month, 3 month and 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index, Gingival index |
1 month, 3 month and 6 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/11/2025 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
A total of 15 chronic periodontitis patients aged 22–55 years with bilateral two- or three-walled defects, probing depth >5 mm, and clinical attachment loss >3 mm will be selected. Sites will be randomized into two groups using the table of random numbers under single blinding. Informed consent will be obtained after explaining the procedure, risks, and benefits. Pre-operative scaling and root planing will be done, and baseline measurements recorded after one month. Surgery will be performed under CHX rinse and povidone-iodine antisepsis. Defects will be filled with either hydrated DFDBA or hydrated BCP, both covered with a chorion membrane. The study aims to evaluate and compare bone regeneration in DFDBA and BCP groups using clinical parameters (Plaque Index, Gingival Index, Probing Pocket Depth, Clinical Attachment Level) at baseline, 3 and 6 months, assess radiographic defect fill and resolution at baseline and 6 months, and record any adverse reactions. |