Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars

NCT ID: NCT03838094

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-09-30

Brief Summary

Aim of the study: To compare the clinical and radiographic outcomes of mineral trioxide aggregate (MTA) and Biodentine as vital pulp therapy materials (pulpotomy) of cariously exposed vital immature mandibular first permanent molars.

Materials and Methods: sixty immature first mandibular permanent molars cariously exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Following split-mouth design molars were randomly assigned to either a control group (MTA 30 molars) or a test group (Biodentine 30 molars). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated molars received permanent restorations. Blinded clinical and radiographic evaluations were performed at different time intervals (base line immediate postoperative, 6, 12 and 18 months) according to clinical and radiographic criteria of success. Data were recorded and analysed.

Detailed Description

Diagnosis:

1. Full history data will be collected, including personal, medical and previous dental data

2. Clinical examination using mirror and probe to assess the inclusion criteria.

3. Radiographic examination using preoperative digital periapical radiograph to assess the inclusion criteria.

4. Preoperative photograph will be taken.

Operative procedure:

Experimental group:

1. Injection of local anesthesia and rubber dam isolation.

2. caries and roof of the pulp chamber will be removed by a fissure diamond bur (Diatech, Heerbrug, Switzerland) and high-speed handpiece with coolant.

3. The pulps will be amputated to the orifice level using a long-shank diamond round bur.

4. Haemostasis will be achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min.

5. Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) will be mixed according to the manufacturer's instructions, radicular pulp will be covered by the material using a wet cotton pellet.

6. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.

7. Immediate post-operative radiograph and photograph will be taken.

Control group:

The same procedures will be carried out as the experimental group, but the pulp stumps will be covered with fast-setting mineral trioxide aggregate (MTA) ENDOCEM MTA (Maruchi, Wonju, Korea) and will be prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA will be placed over the amputated pulps and will be gently adapted to the dentinal walls using a wet cotton pellet. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) will be placed over the pulpotomy agent as a final restoration.

Postoperative care:

Instructions to avoid lip and cheek biting in addition to oral hygiene measures.

Follow up:

Assess the outcomes clinically and radiographically at (baseline, 6, 12 and 18 months).

Conditions

Carious Exposure of Pulp

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

MTA Group

pulpotomy technique using fast-setting mineral trioxide aggregate (MTA) to be considered the control group for vital pulp therapy and was placed over the amputated pulps for 18 months. This group will be compared with the Biodentine group as the intervention group

Group Type: ACTIVE_COMPARATOR

MTA

Intervention Type: BIOLOGICAL

MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping

Biodentine group

3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration

Group Type: EXPERIMENTAL

Biodentine

Intervention Type: BIOLOGICAL

it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.

Interventions

Biodentine

it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.

Intervention Type: BIOLOGICAL

MTA

MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping

Intervention Type: BIOLOGICAL

Other Intervention Names

Calcium silicate-based biomaterial; mineral trioxide aggregate

Eligibility Criteria

Inclusion Criteria

• Bilaterally Symptomatic ⁄ asymptomatic vital immature mandibular first permanent molars (with clinical carious exposure of the pulp and presence of bleeding upon exposure)

• Patients with an age range from 7-8 years.
• Absence of sinus tract, soft tissue swelling.

Exclusion Criteria

• • Molars were excluded if non-restorable.

• excessive mobility (more than 1 mm horizontally).
• Radiographic evidence of peri- and ⁄or inter-radicular lesions, internal⁄ external root resorption, pulp⁄ canal calcifications.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Gihan M Abuelniel ,PhD

OTHER

Sponsor Role: lead

Responsible Party

Gihan M Abuelniel ,PhD

Associate Professor of Pediatric Dentistry

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Gihan M Abuelniel, PhD

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

19119

Identifier Type: -

Identifier Source: org_study_id