| CTRI Number |
CTRI/2025/04/084584 [Registered on: 11/04/2025] Trial Registered Prospectively |
| Last Modified On: |
18/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare & evaluate DFDBA with & without Doxycyline hyclate loaded Proniosomal gel in the chronic periodonitis patients. |
|
Scientific Title of Study
|
Comparative evaluation of Demineralised Freeze Dried Bone Allograft with & without Doxycycline
hyclate loaded Proniosomal 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 Vaishnavi Biradar |
| Designation |
Student |
| Affiliation |
Reader and Guide |
| Address |
104, Department of Periodontics and Implantology Ranjeet Deshmukh Dental
College and Research Centre, Digdoh Hills, Hingna road Nagpur
Nagpur
MAHARASHTRA
440019
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8208810045 |
| Fax |
|
| Email |
vaishnavibiradar1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhawal Mody |
| Designation |
Reader and Guide |
| Affiliation |
Ranjeet Deshmukh Dental College and Research Centre |
| Address |
104, Department of Periodontics and Implantology Ranjeet Deshmukh Dental
College and Research Centre, Digdoh Hills, Hingna road Nagpur
Nagpur
MAHARASHTRA
440019
India
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 Centre |
| Address |
104, Department of Periodontics and Implantology Ranjeet Deshmukh Dental
College and Research Centre, Digdoh Hills, Hingna road Nagpur
Nagpur
MAHARASHTRA
440019
India
Nagpur
MAHARASHTRA
440019
India |
| Phone |
8055775977 |
| Fax |
|
| Email |
periowell@gmail.com |
|
|
Source of Monetary or Material Support
|
| 104, Department of Periodontics, Ranjeet Deshmukh College & Research Centre,
Hingna Nagpur 441110, Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr. Vaishnavi Biradar |
| Address |
Ranjeet Deshmukh Dental College and Research Centre, Digdoh Hills, Hingna
road Nagpur 440019 Maharashtra India |
| 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 Centre |
104, Department of
Periodontics and
Implantology
Hingna-441110, Nagpur
MAHARASHTRA
Nagpur
MAHARASHTRA |
8208810045
vaishnavibiradar1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ranjeet Deshmukh Dental College& Research Centre Institutional Ethical Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Y62-Y69||Misadventures to patients during surgical and medical care, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Doxycycline gel with DFDBA |
Stage III Perioodntitis exhibiting class II furcation defects to be treated with doxycycline gel with
DFDBA Intervention Frequency-once time at the site
Duration 10 days Dose - 1mg per site |
| Comparator Agent |
DFDBA alone |
Stage III Periodontitis exhibiting Class II furcation defects to be treated with DFDBA bone graft
alone. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Month(s) |
| Age To |
60.00 Month(s) |
| Gender |
Both |
| Details |
1) Patients with Stage III periodontitis as assessed by Probing Pocket Depth (PPD)
2) 6mm, interdental clinical attachment level
(CAL)
3) 5 mm and Horizontal Probing Depth (HPD) 2mm
Patients with at least two class II furcation defects in either maxillary or mandibular arch. |
|
| ExclusionCriteria |
| Details |
1) Patients with a history of allergies, Systemic diseases or drug
usage.
2) Patients who have undergone periodontal surgery in previous 6
months.
3) Pregnant or lactating women. |
|
|
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 & compare the efficacy of
doxycycline hyclate loaded proniosomal gel in
combination with DFDBA & DFDBA alone in the
treatment of Class II furcation defects
radiographically by CBCT. |
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess Clinical Attachment Level (CAL),
Probing Pocket Depth (PPD) ,Horizontal Probing
Depth (HPD)and radiographic bone fill in Class II
furcation defects when treated with doxycycline
hyclate loaded proniosomal gel in combination
with DFDBA & DFDBA alone |
at baseline 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="28"
Sample Size from India="28"
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
|
N/A |
|
Date of First Enrollment (India)
|
29/04/2025 |
| 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 - YES
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response (Others) -
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 15-11-2023 and end date provided 29-04-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This randomized clinical study will include 28 patients both males and females visiting the department of Periodontics and Implant Dentistry diagnosed with Stage III Periodontitis and exhibiting Class II furcation defects. Two sites in each patient will be assigned randomly for sampling as follows- It will be conducted in Department of Periodontics and Implant Dentistry, 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 doxcycline hyclate 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: (28 - Control Group) – Stage III Periodontitis exhibiting Class II furcation defects to be treated with DFDBA bone graft alone. Group II: (28- Test Group) – Stage III Perioodntitis exhibiting Class II furcation defects to be treated with doxcycline gel with DFDBA . INCLUSION CRITERIA: 1) Patients with Stage III periodontitis as assessed by Probing Pocket Depth (PPD) ? 6mm, interdental clinical attachment level (CAL) ? 5 mm and Horizontal Probing Depth (HPD) ? 2mm. 2) Patients with at least two class II furcation defects in either maxillary or mandibular arch. EXCLUSION CRITERIA: 1) Patients with a history of allergies, Systemic diseases or drug usage. 2) Patients who have undergone periodontal surgery in previous 6 months. 3) Pregnant or lactating women. 4) Smokers, tobacco chewers and patients with poor oral hygiene index (PI>1.5) will be excluded from the study. 5) Carious teeth or teeth with mobility > Class II |