| CTRI Number |
CTRI/2025/02/080523 [Registered on: 13/02/2025] Trial Registered Prospectively |
| Last Modified On: |
04/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of clinical and radiographic changes in gums and tooth bone in patients with caries below the gum margin filled with glass ionomer cement and composite cement during gum surgery |
|
Scientific Title of Study
|
Comparative evaluation of clinical and radiographic changes in periodontal tissues of patients with subgingival carious lesions restored with resin modified glass ionomer cement versus resin composite with simultaneous open flap debridement : A randomized clinical 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 Kruti Nayak |
| Designation |
PG student |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
Room no.6, dept of Periodontia, !st floor,Government Dental College and Hospital Main Road Rameshwar
Nagar Government Dental College and Hospital Main Road
Rameshwar Nagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9409178214 |
| Fax |
|
| Email |
krutinayak6999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nayana Patel |
| Designation |
PG guide |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
101, 1st floor Gulab Avenue Near Park Colony Jamnagar 361008 Government
Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nayana Patel |
| Designation |
PG guide |
| Affiliation |
Government Dental College and Hospital Jamnagar |
| Address |
101,1st floor Gulab Avenue Near Park Colony Jamnagar 361008 Government
Dental College and Hospital Main Road Rameshwar Nagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT
361008
India |
| Phone |
9825191911 |
| Fax |
|
| Email |
drnayanagpatel@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of periodotia,Government Dental College and Hospital, Navagam ghed, Jamnagar,Gujarat,India 361008 |
|
|
Primary Sponsor
|
| Name |
Dr Kruti Nayak |
| Address |
Government Dental College and Hospital Main Road Rameshwar
Nagar Government Dental College and Hospital Main Road
Rameshwar Nagar
Jamnagar
GUJARAT
India
361008 |
| 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 Kruti Nayak |
Government Dental College and Hospital Jamnagar |
Room no.6, Department of Periodontia, 1st floor, Government Dental College and Hospital Main Road Rameshwar
Nagar Government Dental College and Hospital Main Road
Rameshwar Nagar
Jamnagar
GUJARAT
361008
India
Jamnagar
GUJARAT |
9409178214
krutinayak6999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee MP Shah Medical College and Guru Govind Singh Government Hospital |
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 |
RESIN COMPOSITE |
After endodontic treatment if needed and phase 1 therapy patients will be recalled and evaluated.Baseline data of clinical and radiographic parameters will be recorded. Patient preparation will be done and local anesthesia will be given.Flap surgery will be performed for assisting the restorative procedure since it could aid in establishing a proper access to the operative site, debriding the area and rendered attachment at a desirable area favoring less recession post-operatively. Group B will be restored with resin composite. 4-0 suture will be passed through buccal and lingual papilla and suture will be placed.Post-operative instructions will be given. Patient will be prescribed with antibiotics and analgesics for 5 days.Sutures will be removed one week post operatively.Follow up after 3 months and 6 months will be taken and clinical changes which are plaque index gingival index probing pocket depth and clinical attachment level and radiographic changes which is bone height will be recorded |
| Intervention |
Resin modified glass ionomer cement |
After endodontic treatment if needed and phase 1 therapy patients will be recalled and evaluated.Baseline data of clinical and radiographic parameters will be recorded.
Patient preparation will be done and local anesthesia will be given.Flap surgery will be performed for assisting the restorative procedure since it could aid in establishing a proper access to the operative site, debriding the area and rendered attachment at a desirable area favoring less recession post-operatively.
Group A will be restored with resin modified glass ionomer cement. 4-0 suture will be passed through buccal and lingual papilla and suture will be placed.Post-operative instructions will be given. Patient will be prescribed with antibiotics and analgesics for 5 days.Sutures will be removed one week post operatively.Follow up after 3 months and 6 months will be taken and clinical changes which are plaque index gingival index probing pocket depth and clinical attachment level and radiographic changes which is bone height will be recorded
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
No systemic conditions that would contraindicate routine periodontal procedures
The sites having radiographic evidence of subgingival caries and probing depth of equal to or greater than 4 mm |
|
| ExclusionCriteria |
| Details |
Patients with deleterious oral habits such as smoking, tobacco chewing.
Pregnant and lactating mothers.
Patients who were on anti inflammatory drugs consumption within the past 3 months
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth |
Baseline 3 months 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Plaque index (PI)
Gingival index (GI)
Clinical attachment level(CAL)
Bone height
|
Baseline 3rd month 6th 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 4 |
|
Date of First Enrollment (India)
|
17/03/2025 |
| 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 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
|
Patient referred to the department of periodontia, will be screened for subgingival carious lesions. After fulfilling the inclusion and exclusion criteria patient will be informed. After informing the patient about the study and completing the formalities in the consent form, the patients will be enrolled and data collection in the proforma will be done. After endodontic treatment if needed and phase 1 therapy patients will be recalled and evaluated. Baseline data of clinical parameters which are Plaque index (PI) Gingival index (GI) Probing pocket depth (PD) Clinical attachment level (CAL) and radiographic parameters which is bone height will be recorded. Patient preparation will be done and local anesthesia will be given. Flap surgery will be performed for assisting the restorative procedure since it could aid in establishing a proper access to the operative site, debriding the area and rendered attachment at a desirable area favoring less recession post-operatively. Group A will be restored with resin modified glass ionomer cement group. Group B will be restored with resin composite. 4-0 suture will be passed through buccal and lingual papilla and suture will be placed. Post-operative instructions will be given. Patient will be prescribed with antibiotics and analgesics for 5 days. Sutures will be removed one week post operatively. Follow up after 3 months and 6 months will be taken and clinical and radiographic changes will be recorded. |