Evaluation of MTA Versus Biodentine as Pulpotomy Agents in Immature First Permanent Molars
- Conditions
- Carious Exposure of Pulp
- Interventions
- Biological: BiodentineBiological: MTA
- Registration Number
- NCT03838094
- Lead Sponsor
- Gihan M Abuelniel ,PhD
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
-
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.
-
• 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Biodentine group Biodentine 3 mm- thick Biodentine covered radicular pulp to allow pulp regeneration MTA Group MTA 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
- Primary Outcome Measures
Name Time Method pain, sensitivity to percussion⁄ palpation 18 months by asking the patient( binary measure)Yes or No, where Yes indicates presence of pain that shows clinical failure
Swelling or sinus tract 18 months by visual examination( Binary measure) (Yes or No) where No indicates success of the treatment
tooth mobility 18 months by back of the mirror( Binary measure) (Yes or No) where No mobility indicates success of the treatment
- Secondary Outcome Measures
Name Time Method root formation/development stage 18 months 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)
Crown: Root ratio 18 months by radiographic parallel technique ( the ratio 2:1 or more than 2:1) the ratio more than 2:1 is the best
Apical closure 18 months by radiographic parallel technique( the apex is blunder apex ,partially open, or constricted) blunder apex is the worse and constricted apex is the best.
presence of radiolucency 18 month by radiographic parallel technique( binary measure)( yes or No) if radiolucency is detected this indicates failure of the treatment