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

Clinical and Radiographic Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: Carious Exposure of Pulp
• Intervention / Treatment: Biological: MTA; Biological: Biodentine

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).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 7 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	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; Other Names: mineral trioxide aggregate
Experimental: Biodentine group; 3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration	Biological: 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.; Other Names: Calcium silicate-based biomaterial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain, sensitivity to percussion⁄ palpation	by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure	18 months
Swelling or sinus tract	by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment	18 months
tooth mobility	by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment	18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
root formation/development stage	by radiographic parallel technique to measure the maturity scores used during the radiographic assessment of root development are F, G and H (where F is the worse and H is the best stage)	18 months
Crown: Root ratio	by radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best	18 months
Apical closure	by radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best.	18 months
presence of radiolucency	by radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment	18 month

Collaborators and Investigators

• Sponsor: Gihan M Abuelniel ,PhD
• Collaborators: Cairo University
• Investigators: Principal Investigator: Gihan M Abuelniel, PhD, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: February 6, 2019
• First Submitted That Met QC Criteria: February 8, 2019
• First Posted (Actual): February 12, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: MTA; Biodentine; vital immature; pulp exposure
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Calcium
• Other Study ID Numbers: 19119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: only final results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No