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

NCT03119779 | Completed DMC

• 1 other identifier: CEBD-CU-2014-09-15
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Caries, Dental

Keywords

pulpotomy; deep caries; permanent molars; MTA

Outcome Measures

Primary Outcomes (1)

• Survival rate

  absence of any complication or complementary treatment (absence of spontaneous pain or swelling)

  12 months

Secondary Outcomes (3)

• periapical radiolucency

  12 months

• internal/ external root resorption

  12 months

• Root maturation

  12 months

Other Outcomes (1)

• Time lapse till final restoration performed

  from 5 till 20 minutes

Study Arms (2)

TheraCal vital pulp therapy

EXPERIMENTAL

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.

Drug: TheraCal

MTA vital pulp therapy

ACTIVE COMPARATOR

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.

Drug: MTA-Anglus

Interventions

MTA-Anglus 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.

Also known as: MTA-Anglus vital pulp therapy

MTA vital pulp therapy

TheraCal 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.

Also known as: TheraCal vital pulp therapy

TheraCal vital pulp therapy

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Dental Caries

Interventions

TheraCal

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Passant Nagi, MSc

  Assisternt lecturer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: April 19, 2017
• Study Start: September 1, 2015
• Primary Completion: April 30, 2017
• Study Completion: April 30, 2017
• Last Updated: July 25, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share