Effect of Pulpotomy Using TheraCal Versus MTA on Survival Rate of Cariously-Exposed Vital Permanent Molars

NCT ID: NCT03119779

Last Updated: 2017-07-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-04-30

Brief Summary

Objective:

To assess which is the most efficient pulpotomy medicament on tooth survival in patients with a cariously-exposed vital young permanent molar regarding: absence of postoperative pain, sinus or swelling, internal/ external root resorption, periapical radiolucency), root maturation and decrease chair side time of treated patient.

Trial design Randomized Clinical Trial (RCT), double-blinded with parallel group and allocation ratio (1:1), equivalence framework.

Detailed Description

Preoperative records will be taken (photos, conventional periapical radiographs, and impression to construct acrylic stent to help standardization on follow up apical radiographs). Administration of inferior alveolar nerve block then using rubber dam isolation one of the investigators will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. Then the pulp status will be assessed if bleeding is controlled with direct irrigation with distilled water for 2 minutes then next step will be taken but if not continue excavation of the pulp till bleeding is controlled. if bleeding is not controlled after performing complete pulpotomy, tooth will be excluded from the study Then direct application of capping materials (TheraCal or MTA) according to manufacturer instructions, then Riva self-cure glass-ionomer base and composite resin final restoration. One of the investigators will take immediate standardized postoperative periapical radiographs. Follow-up will be for 12 months. Pre-calibrated blinded dentists will assess out comes separately.

Conditions

Caries, Dental

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

TheraCal vital pulp therapy

Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of incremental layers of TheraCal using the tip of the syringe container of the material and each layer should not exceed 1 mm then light curing each increment. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.

Group Type: EXPERIMENTAL

TheraCal

Intervention Type: DRUG

TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.

MTA vital pulp therapy

Using rubber dam isolation we will remove the caries using large round but under copious amount of coolant and if carious exposure occur, part of the pulp chamber will be removed using sharp spoon excavator. After complete removal of the caries and control of bleeding, then direct application of freshly mixed MTA-Anglus on sterile glass slap. MTA application then gentle condensation over wet cotton till MTA thickness is about 2-3 mm thickness and removal of excess material from walls of pulp chamber. Application of wet cotton for 15 min. to achieve initial setting of MTA. Then Riva self-cure glass-ionomer base and composite resin final restoration. We will take immediate standardized postoperative periapical radiographs.

Group Type: ACTIVE_COMPARATOR

MTA-Anglus

Intervention Type: DRUG

MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.

Interventions

MTA-Anglus

MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.

Intervention Type: DRUG

TheraCal

TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.

Intervention Type: DRUG

Other Intervention Names

MTA-Anglus vital pulp therapy; TheraCal vital pulp therapy

Eligibility Criteria

Inclusion Criteria

• Restorable permanent molars with deep caries and pain could be relieved with analgesics

Exclusion Criteria

• criteria of exclusion of teeth were:

• pathological mobility, swelling or tenderness to percussion/palpation;
• pathology is shown in the pre-operative radiographic as resorption periradicular or furcation radiolucency, or a widened periodontal ligament space;
• at the operative procedure, hemorrhage control is unachievable

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 9 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Passant Nagy

Assistant lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Passant Nagi, MSc

Role: PRINCIPAL_INVESTIGATOR

Assisternt lecturer

Other Identifiers

CEBD-CU-2014-09-15

Identifier Type: -

Identifier Source: org_study_id