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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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03838094
Enrollment
30
Registered
2019-02-12
Start date
2016-02-29
Completion date
2018-09-30
Last updated
2019-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carious Exposure of Pulp

Keywords

pulp exposure, vital immature, MTA, Biodentine

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).

Interventions

BIOLOGICALBiodentine

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.

BIOLOGICALMTA

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

Sponsors

Cairo University
CollaboratorOTHER
Gihan M Abuelniel ,PhD
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
7 Years to 8 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Swelling or sinus tract18 monthsby visual examination( Binary measure) (Yes or No) where No indicates success of the treatment
pain, sensitivity to percussion⁄ palpation18 monthsby asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure
tooth mobility18 monthsby back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment

Secondary

MeasureTime frameDescription
root formation/development stage18 monthsby 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)
presence of radiolucency18 monthby radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment
Crown: Root ratio18 monthsby radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best
Apical closure18 monthsby radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026