Clinical trial NCT03838094: Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars
Official title: Clinical and Radiographic Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Carious Exposure of Pulp
Keywords: pulp exposure
vital immature
MTA
Biodentine
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2019-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: pain, sensitivity to percussion⁄ palpation
timeFrame: 18 months
measure: Swelling or sinus tract
timeFrame: 18 months
measure: tooth mobility
timeFrame: 18 months
Secondary outcomes:
measure: root formation/development stage
timeFrame: 18 months
measure: Crown: Root ratio
timeFrame: 18 months
measure: Apical closure
timeFrame: 18 months
measure: presence of radiolucency
timeFrame: 18 month
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Gihan M Abuelniel, PhD
role: PRINCIPAL_INVESTIGATOR
References: