| CTRI Number |
CTRI/2024/03/064482 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Other |
|
Public Title of Study
|
A clinical study comparing outcome of regenerative root canal treatment with and without chitosan loaded triple antibiotic paste. |
|
Scientific Title of Study
|
Evaluation of Regenerative Potential of Pulp in Necrotic Mature teeth using Chitosan-Loaded Triple Antibiotic paste: A Randomised clinical trial. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Asiya Sameer Mujawar |
| Designation |
Associate Professor |
| Affiliation |
M.A.Rangoonwala college of dental science and research centre |
| Address |
Department of conservative dentistry and Endodontics ,second floor 305 room .
M.A.Rangoonwala college of dental science and research centre.
Azam campus 2390-B,K.B,Hidayatulla Rd.Camp .
Pune
MAHARASHTRA
411001
India |
| Phone |
9552978658 |
| Fax |
|
| Email |
drasiyashaikh786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asiya Sameer Mujawar |
| Designation |
Associate Professor |
| Affiliation |
M.A.Rangoonwala college of dental science and research centre |
| Address |
Department of conservative dentistry and Endodontics ,second floor 305 room .
M.A.Rangoonwala college of dental science and research centre.
Azam campus 2390-B,K.B,Hidayatulla Rd.Camp .
Pune
MAHARASHTRA
411001
India |
| Phone |
9552978658 |
| Fax |
|
| Email |
drasiyashaikh786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asiya Sameer Mujawar |
| Designation |
Associate Professor |
| Affiliation |
M.A.Rangoonwala college of dental science and research centre |
| Address |
Department of conservative dentistry and Endodontics ,second floor 305 room .
M.A.Rangoonwala college of dental science and research centre.
Azam campus 2390-B,K.B,Hidayatulla Rd.Camp .
Pune
MAHARASHTRA
411001
India |
| Phone |
9552978658 |
| Fax |
|
| Email |
drasiyashaikh786@gmail.com |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth dental college
Pune-satara road,katraj -ambegaon BKRd,Dhankawadi,Pune |
|
|
Primary Sponsor
|
| Name |
Dr.Asiya Mujawar |
| Address |
Azam campus 2390-B ,K.B,Hidyatilla Rd,Camp ,Pune i |
| Type of Sponsor |
Other [Individual] |
|
|
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 |
| DrAsiya Mujawar |
Bharati vidyapeeth dental college |
department of conservative dentistry and endodontics ,second floor ,room number 104Pune-satara road ,Katraj-Ambegaon Bk Rd,Dhankawadi.
Pune
MAHARASHTRA |
9552978658
drasiyashaikh786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Bharati Vidyapeeth Dental college and hospital ,Pune |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
chronic apical periodontitis |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional root canal treatment |
Local anesthesia will be delivered followed by rubber dam isolation, straight-line access cavity was performed. The working length was determined using an apex locator and confirmed using a periapical radiograph and a CBCT. After coronal flaring, the root canal will be enlarged at the working length up to 5 or 6 sizes larger than the first binding file size. The root canals will be prepared using rotary files and stainless-steel hand files ( During canal preparation, the canal patency will be reestablished using a #10 K-file, and the root canal was irrigated with 2 mL 1% sodium hypochlorite (NaOCl) between each file. After completion of the preparation, a final irrigation will be performed with 5 mL 1% NaOCl followed by the same amount of 5% EDTA for 1 minute each. The root canal will be dressed with calcium hydroxide paste for 1 week, and the access cavity will be filled with a sterile cotton pellet and temporary filling material after 1 week, the medicament will be removed by 5% EDTA activated passively using a noncutting ultrasonic instrument for 1 minute, and the final irrigation will be performed with 5 mL distilled water. All irrigation procedures will be performed with a 30-G needle 3 mm above the working length. After which the root canals will be dried with paper points, the canals will be filled with gutta-percha cones and AH plus sealer using the cold lateral compaction technique. The access cavity will be restored with a resin composite material.
|
| Intervention |
Regenerative procedure with Triple antibiotic paste |
Local anesthesia will be delivered followed by rubber dam isolation, straight-line access cavity was performed. The working length was determined using an apex locator and confirmed using a periapical radiograph . After coronal flaring, the root canal will be enlarged at the working length up to 5 or 6 sizes larger than the first binding file size. The root canals will be prepared using rotary files. During canal preparation, the canal patency will be reestablished using a #10 K-file, and the root canal was irrigated with 2 mL 1% sodium hypochlorite (NaOCl) between each file. After completion of the preparation, a final irrigation will be performed with 5 mL 1% NaOCl followed by the same amount of 5% EDTA for 1 minute eachTo avoid coronal discoloration, a resin bond will be applied without etching into the access cavity walls and the coronal third of the root canal. A triple antibiotic paste (doxycycline, metronidazole, and ciprofloxacin) will be applied in the middle and apical thirds of the root canals for 3 weeksAt the second visit, local infiltration anesthesia without vasoconstrictor will be injected. The triple antibiotic paste will be removed ultrasonically using passively activated distilled water followed by 5 mL 1% NaOCl for 1 minute. The root canal will then be irrigated with 2 mL 5% EDTA for 1 minute. A final irrigation will be performed using 5 mL distilled water, and the root canal will be dried with paper points. Bleeding will be induced in the canal by passing a #25 sterile K-file beyond the apex. After the bleeding became visible in the canal, a dry cotton pellet will be inserted 3 mm into the canal for 5 minutes to allow blood clot formation. MTA will placed approximately 3 mm below the cementoenamel junction, and the access cavity will be restored with a temporary filling material . The following day, the temporary filling will be replaced with a resin composite material.
|
| Intervention |
Regenerative procedure with Triple antibiotic paste loaded with chitosan nanoparticles |
Local anesthesia will be delivered followed by rubber dam isolation, straight-line access cavity was performed. The working length was determined using an apex locator and confirmed using a periapical radiograph . After coronal flaring, the root canal will be enlarged at the working length up to 5 or 6 sizes larger than the first binding file size. The root canals will be prepared using rotary files. During canal preparation, the canal patency will be reestablished using a #10 K-file, and the root canal was irrigated with 2 mL 1% sodium hypochlorite (NaOCl) between each file. After completion of the preparation, a final irrigation will be performed with 5 mL 1% NaOCl followed by the same amount of 5% EDTA for 1 minute eachTo avoid coronal discoloration, a resin bond will be applied without etching into the access cavity walls and the coronal third of the root canal. A triple antibiotic paste (doxycycline, metronidazole, and ciprofloxacin)loaded with chitosan will be applied in the middle and apical thirds of the root canals for 3 weeksAt the second visit, local infiltration anesthesia without vasoconstrictor will be injected. The triple antibiotic paste will be removed ultrasonically using passively activated distilled water followed by 5 mL 1% NaOCl for 1 minute. The root canal will then be irrigated with 2 mL 5% EDTA for 1 minute. A final irrigation will be performed using 5 mL distilled water, and the root canal will be dried with paper points. Bleeding will be induced in the canal by passing a #25 sterile K-file beyond the apex. After the bleeding became visible in the canal, a dry cotton pellet will be inserted 3 mm into the canal for 5 minutes to allow blood clot formation. MTA will placed approximately 3 mm below the cementoenamel junction, and the access cavity will be restored with a temporary filling material . The following day, the temporary filling will be replaced with a resin composite material. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. patients in the age range of 18–30 years without systematic disease/allergic reactions
2. Nonvital single- rooted teeth (anterior or premolars) encasing 1 root canal with mature roots (closed apices) and a periapical lesion score ≥3 according to Ostravik et al.
Score 1: Normal periapical structure
Score 2: Small changes in bone structure
Score 3: Changes in bone structure with mineral loss
Score 4: Periodontitis with well-defined radiolucency
Score 5: Severe periodontitis with exacerbating factors |
|
| ExclusionCriteria |
| Details |
1. Medically compromised patients (with immunosuppressive/systemic diseases, patients on medications) - periodontologically compromised teeth.
2. Endodontically treated teeth
3. Teeth with periapical lesions more than 5 mm in diameter.
4. Patients who refuse to participate.
5. Anatomical variations leading to inability to reach the full working length. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the regenerative potential of pulp in necrotic mature teeth with and without chitosan loaded triple antibiotic paste. |
The outcome will be assessed at 6months and 1 year . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Vitality of tooth |
the vitality of the tooth will be assessed with electric pulp testing device after 6 months and 1 year of the treatment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
08/04/2024 |
| Date of Study Completion (India) |
20/02/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
20/02/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
The regenerative endodontic procedure represents a transformative approach to preserving dental pulp vitality and restoring damaged infected teeth. According to the literature, very few clinical studies are reported which evaluate the clinical outcome using chitosan-loaded triple antibiotic. Chitosan, a biocompatible and biodegradable polymer has gained attention as an ideal carrier for drug delivery. This study aims to assess the clinical outcome of regenerative endodontic procedures in mature necrotic teeth with and without chitosan-loaded triple antibiotic paste. |