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Pulpotomy Technique Preserving Vitality of Traumatized Anterior Permanent Immature Teeth

Clinical and Radiographic Evaluation of Pulpotomy Technique for Preserving Vitality of Traumatized Anterior Permanent Immature Teeth: A Randomized Clinical Trial

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03838068
Enrollment
33
Registered
2019-02-12
Start date
2017-01-18
Completion date
2019-08-15
Last updated
2019-12-27

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

Conditions

Pulp Exposure, Dental

Keywords

trauma, 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) preserving the vitality of traumatized immature anterior permanent teeth. Materials and Methods: fifty vital traumatized immature anterior permanent teeth exposed with symptomatic /asymptomatic pulpitis were included in the study according to inclusion criteria and were equally divided in two groups. Included teeth were randomly assigned to either a control group (MTA 25 teeth) or a test group (Biodentine 25 teeth). After conducting pulpotomy and covering pulp stumps with the MTA and Biodentine, treated teeth 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 analyzed.

Detailed description

Informed consent was obtained from all patients prior to treatment, and patients were offered Root canal treatment in case of treatment failure. Thirty-three patients who were referred to the postgraduate pediatric dentistry department clinic for the management of their traumatized permanent incisors teeth were assessed. Only Patients who had a traumatic incisor tooth with a vital pulp (detected by clinical signs/symptoms) were included. Incisors were assigned randomly in the two groups. The MTA group was considered the control group while the biodentine was the test group. All patients who were clinically eligible for enrollment in the study went through screening pre-operative digital periapical radiographic examination to assess the degree of root development/ formation and any dental infections or anomalies that could interfere with the planned treatment. The main investigator performed all pulpotomies. Local anesthesia was administrated followed by rubber dam isolation, the coronal pulp tissue was excised to the level of the orifice using a diamond bur with water cooling. Hemostasis was achieved by gentle placement of a saline-moistened cotton pellet over amputated pulps for 5-10 min. Pulp stumps were covered with: In the first group (control group) white mineral trioxide aggregate (MTA) ProRoot® MTA (Dentsply/ Johnson City,TN,USA) was used as the reference material for comparison and was prepared according to the manufacturer's instructions. A 3-mm-thick layer of MTA was placed over the amputated pulps and was gently adapted to the dentinal walls using a wet cotton pellet deep onto the radicular pulp. A self-cure glass ionomer (GC; GC Corporation, Tokyo, Japan) was placed over the pulpotomy agent before final restoration of composite resin (ClearfilTM, Kuraray, New York, USA) was done. In the second group Calcium silicate-based BiodentineTM (Septodont Ltd., Saint Maur des Fausse´s, France) was mixed according to the manufacturer's instructions, pulpotomy was performed, radicular pulp was covered, and teeth received self-cure glass ionomer prior to final restoration with the same technique as in the first group.

Interventions

BIOLOGICALBiodentine

Biodentine is considered a calcium silicate cement

BIOLOGICALmineral trioxide aggregate

calcium based silicate cement

coronal pulp tissue was removed till the orifice

DRUGLocal Anesthetics Procaine

40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance

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)

Masking description

Patients and their parents, the assessor and the statistician will be blinded.

Intervention model description

Access cavity in traumatized central incisors will be assigned into experimental or control group using simple randomization 1:1 by the help of the computer software(random.org).

Eligibility

Sex/Gender
ALL
Age
7 Years to 9 Years
Healthy volunteers
Yes

Inclusion criteria

* The patient age range 7.5-9 years. * Noncontributory medical history * Unilateral/ and or bilateral central incisors tooth with complicated trauma (exposure size ≥ 1mm) * The tooth should give positive response to cold testing * Clinical diagnosis of reversible pulpitis without periapical rarefaction * The tooth is restorable, mobility was within normal limits * No signs of pulpal necrosis including sinus tract or swelling

Exclusion criteria

* Teeth with mature roots * Signs and symptoms of irreversible pulpitis * Non-restorable teeth * Negative response to cold testing, the presence of sinus tract or swelling * No pulp exposure * Bleeding could not be controlled after full pulpotomy in 6 minutes

Design outcomes

Primary

MeasureTime frameDescription
presence of pain,sensitivity to percussion/ palpation18 monthsby asking the patient( questionnaire) (Binary measure) ( Yes or No) where Yes indicates failure of the treatment
Swelling or sinus tract18 monthsby visual examination (binary measure)( Yes or No) where Yes indicates clinical failure of the treatment
presence of mobility18 monthsby the back of the mirror( Binary measure) (Yes or No) where Yes indicates clinical failure of the treatment.

Secondary

MeasureTime frameDescription
Stage of root development18 monthsby radiographic parallel technique ( four root development stages are assessed E, F,G and H) where E is the worse and H is the best stage.
Presence of radiolucency18 monthsby radiographic parallel technique (Binary measure) (Yes or No) where Yes indicates radiographic failure of the treatment.

Countries

Egypt

Outcome results

None listed

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