| CTRI Number |
CTRI/2025/03/081910 [Registered on: 07/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Bone Graft with and without Spirulina Gel in Treating Bone Defect: A Clinical Trial |
|
Scientific Title of Study
|
Comparative Evaluation of Demineralised Freeze-Dried Bone Allograft with and without Spirulina Gel in the treatment of Class II Furcation Defects: A Randomized Controlled 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 |
Dr Tasneem Azad |
| Designation |
Post-Graduate Student |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
104, Dept of Periodontology and Implantology Ranjeet Deshmukh Dental College and Research Center Digdoh Hills, Higna Road, Nagpur-440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
07773945522 |
| Fax |
|
| Email |
tasneemazad3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhawal Mody |
| Designation |
Reader and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
104, Dept of Periodontology and Implantology,Ranjeet Deshmukh Dental College and Research Center Digdoh Hills, Higna Road, Nagpur-440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhawal Mody |
| Designation |
Reader and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Center |
| Address |
104, Dept of Periodontology and Implantology,Ranjeet Deshmukh Dental College and Research Center Digdoh Hills, Higna Road, Nagpur-440019
Nagpur
MAHARASHTRA
440019
India |
| Phone |
08055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104,Department of Periodontics and Implantology,Ranjeet Deshmukh College and Research center Nagpur-440019 India |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
104, Dept of Periodontology and implantology,Ranjeet Deshmukh Dental College and research center Nagpur-440019 |
| 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 Dhawal Mody |
Ranjeet Deshmukh Dental College and Research Center |
104, Department of Periodontics and Implantology Nagpur,MAHARASHTRA
Nagpur
MAHARASHTRA |
08055775977
periowell@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College and Research Centre Ethics Committee |
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 |
DFDBA alone |
Stage III Periodontitis patients aged 30 - 60 years exhibiting 25
Class Il furcation defects to be treated with DFDBA and bone graft alone. |
| Intervention |
Spirulina gel with DFDBA |
Stage III Periodontitis aged 30 to 60 patients exhibiting
25 Class Il furcation defects to be treated with spirulina gel with DFDBA
Intervention Frequency
-one time at the site
|
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients with stage III Periodontitis as assessed by Probing Pocket Depth (PPD) more than or equal to 6mm ,interdental clinical attachment level (CAL) more than or equal to 5 mm and Horizontal Probing Depth (HPD) more than or equal 2mm.
2) Bilateral buccal or lingual Class II furcation involvement
|
|
| ExclusionCriteria |
| Details |
1.Patients with history of systemic diseases, allergies or drug usage.
2.Patients who have undergone periodontal treatment in previous 6 months.
3.Pregnant and lactating females.
4.Smokers or tobacco chewers |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare the effectiveness of DFDBA with and without Spirulina gel in the treatment of Class II Furcation defects clinically and radiographically by CBCT. |
at baseline,3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Assess clinical parameters (CAL, PPD, HPD) in Class II furcation defects treated with Spirulina gel + DFDBA and DFDBA alone.
2. Evaluate radiographic bone fill using CBCT in defects treated with Spirulina gel + DFDBA and DFDBA alone.
3. Compare the clinical and radiographic outcomes between Spirulina gel + DFDBA and DFDBA alone over time. |
baseline, 3, and 6 months. |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
28/07/2025 |
| 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
|
This study will include patients visiting the
department of Periodontics and Implantology diagnosed with Stage III
Periodontitis and exhibiting Class II furcation defects. Two sites in each
patient will be assigned randomly for sampling.
It will be conducted in Department of Periodontics
and Implantology, after taking informed consent from the patient. All the
clinical and radiographical parameters will be evaluated at baseline after
which the sites in the patients will be randomly and equally divided into Test
and Control groups to be treated with Spirulina gel with DFDBA and DFDBA alone
respectively in Class II furcation defects in Stage III Periodontiits patients.
The study will be initiated after clearance from the Institutional Ethics
Committee. For each patient two sites will be randomly assigned as;
Group I: (Control Group) – Stage
III Periodontitis exhibiting bilateral Class II furcation defects to be treated with DFDBA alone.
Group II: (Test Group) - Stage III Periodontitis
exhibiting bilateral Class II furcation
defects to be treated with DFDBA with Spirulina gel.
Pre-surgical Hygiene
Therapy Initial therapy will consist of detailed
oral hygiene instructions and Scaling and root planing. Prior to initiating the
study, its purpose and design will be explained and written informed consent
will be signed by every patient.
Surgical procedure: Under
local anaesthesia, full thickness mucoperiosteal flaps will be reflected and
granulation tissue will be debrided. The root surfaces will be scaled and
planed. In Group I the Class II furcation defects will be treated with DFDBA alone
while in Group II the Class II furcation defects will be treated using DFDBA with
Spirulina gel. The flaps will be sutured back to their original position.
Periodontal dressing will be placed at the surgical sites.
Post-surgical Care: Patient
will be placed on antibiotics and analgesics. Sutures will be removed after 7
days. Clinical results will be evaluated at 3 and 6 months post-operatively and
radiographic evaluation will be performed at 6 months post-operatively by CBCT.
|