Long term evaluation of success and survival Of Immature Permanent Teeth Treated with Different treatment Protocols

Phase 4

Completed

• Conditions: Necrosis of pulp,

• Registration Number: CTRI/2020/02/023603
• Lead Sponsor: maulana Azad Institute of Dental Sciences

Brief Summary

The conventional treatment modality (Apexification) for the management of immature teeth doesn’t allow for any increase in root dimensions of immature teeth. To overcome this problem regenerative treatment has gained popularity in recent years. Regenerative endodontic treatment (RET) promotes increase in root length/width which might have a positive influence on the stress pattern in immature teeth. RET commonly use provoked apical bleeding into the canal space for creating a blood clot. Recently, injectable platelet rich fibrin has shown promising regenerative efficacy. Hence, this randomized controlled trial will be conducted on patients presenting with necrotic immature teeth with incomplete root development to compare these treatment modalities. We hypothesize that there will be no significant difference in the clinical success and radiographic root development among the three groups. Following the inclusion and exclusion criteria, 60 patients will be enrolled for the study and they will be randomly divided into 3 equal groups of 20 each ( group 1, group 2, group 3).  Group 1 will be treated with MTA Apexification, Group 2: Regenerative endodontic treatment with blood clot, Group 3: Regenerative endodontic treatment supplemented with injectable platelet rich fibrin. The patients will be recalled after 6, 12, 18 months for clinical and radiographic follow up. Pre operative and final postoperative (18 months) Cone beam computed tomography (CBCT) images will be imported into image analyzing software. Thereafter changes in root dimensions between the preoperative and final postoperative images will be evaluated by measuring the changes in root length, dentin wall thickness and apical foramen width. The clinical success, survival, radiographic root development will be evaluated and compared amongst three groups. In addition, Stress distribution pattern will be analyzed using cone beam computed tomography based finite model analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-03
• Last Update Posted: 2022-12-15

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Immature necrotic permanent teeth showing clinical and radiographic diagnosis of pulp necrosis with or without periapical involvement 2.Radiographically the tooth has an open apex (> 1mm) 3.Age of the patient: 13-30 years.

Exclusion Criteria

1.Medical conditions that would contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense), 2.Remaining crown/root structure with questionable restorability 3.Teeth with vertical fractures 4.Periodontally involved teeth 5.Lack of patient and parent cooperation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the resolution of clinical symptoms and the evidence of osseous healing on CBCT evaluation	6,12,18 months

Secondary Outcome Measures

Name	Time	Method
Increase in root wall thickness, increase in root length and decrease in apical diameter on CBCT evaluation	6,12,18 months

Trial Locations

Locations (1)

Maulana Azad Institute of dental sciences; 🇮🇳 Central, DELHI, India

Maulana Azad Institute of dental sciences

🇮🇳Central, DELHI, India

Dr Sangeeta Talwar

Principal investigator

9654700950

sangeeta.talwar@gmail.com