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

Sponsor

Cairo University (Other)

Overall Status

Completed

CT.gov ID

NCT03119779

Collaborator

(none)

Enrollment

Arms

19.9

Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries, Dental	Drug: MTA-Anglus Drug: TheraCal	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Apr 30, 2017

Actual Study Completion Date :

Apr 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: TheraCal vital pulp therapy
Active Comparator: 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.	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. Other Names: MTA-Anglus vital pulp therapy

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

TheraCal vital pulp therapy

Active Comparator: 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.

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.

Other Names:

MTA-Anglus vital pulp therapy

Outcome Measures

Primary Outcome Measures

Survival rate [12 months]
absence of any complication or complementary treatment (absence of spontaneous pain or swelling)

Secondary Outcome Measures

periapical radiolucency [12 months]
presence or absence of periapical radiolucency radiographically
internal/ external root resorption [12 months]
presence or absence of internal/ external root resorption radiographically
Root maturation [12 months]
Root maturation assessment radiographically

Other Outcome Measures

Time lapse till final restoration performed [from 5 till 20 minutes]
measured using stop watch to assess which material needs less chair side time to be finished.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 9 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Passant Nagi, MSc, Assisternt lecturer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Passant Nagy, Assistant lecturer, Cairo University

ClinicalTrials.gov Identifier:

NCT03119779

Other Study ID Numbers:

CEBD-CU-2014-09-15

First Posted:

Apr 19, 2017

Last Update Posted:

Jul 25, 2017

Last Verified:

Jul 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Passant Nagy, Assistant lecturer, Cairo University

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Jul 25, 2017