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

Caries, Dental Clinical Trial

Official title:

The Effect of Pulpotomy (Partial or Complete) Using Resin-Modified Calcium Silicate Versus MTA-Anglus on Survival Rate of Cariously-Exposed Vital Young Permanent Molars:A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03119779
• Other study ID #: CEBD-CU-2014-09-15
• Status: Completed
• Phase: N/A
• First received: April 11, 2017
• Last updated: July 21, 2017
• Start date: September 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: July 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: April 30, 2017
• Est. primary completion date: April 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries, Dental
• Dental Caries

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time lapse till final restoration performed	measured using stop watch to assess which material needs less chair side time to be finished.	from 5 till 20 minutes
Primary	Survival rate	absence of any complication or complementary treatment (absence of spontaneous pain or swelling)	12 months
Secondary	periapical radiolucency	presence or absence of periapical radiolucency radiographically	12 months
Secondary	internal/ external root resorption	presence or absence of internal/ external root resorption radiographically	12 months
Secondary	Root maturation	Root maturation assessment radiographically	12 months