Indirect Pulp Treatment in Primary Molars

Phase 4

Completed

• Conditions: Dental Caries
• Interventions: Drug: Indirect pulp treatment using Dycal (TM); Drug: Indirect pulp treatment using Vitrebond (TM )

• Registration Number: NCT03770871
• Lead Sponsor: Cairo University

Brief Summary

This study was conducted to evaluate the clinical and the radiographic success of Dycal and Vitrebond as indirect pulp treatment materials in primary molars.

Detailed Description

Evaluation of calcium hydroxide and resin modified glass ionomer liner clinically and radiographically as indirect pulp treatment materials in deep caries in primary molars.

Study Timeline

• Study Start: 2016-08
• Primary Completion: 2017-08
• Study Completion: 2018-07
• Study First Submitted: 2018-08-18
• Study First Submitted QC: 2018-12-07
• Study First Posted: 2018-12-10
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-28
• Last Update Posted: 2019-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IPT using Dycal (TM )	Indirect pulp treatment using Dycal (TM)	Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
IPT using Dycal (TM )	Indirect pulp treatment using Vitrebond (TM )	Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal
IPT using Vitrebond (TM )	Indirect pulp treatment using Dycal (TM)	Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal
IPT using Vitrebond (TM )	Indirect pulp treatment using Vitrebond (TM )	Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal

Primary Outcome Measures

Name	Time	Method
Number of cases reporting swelling	12 months	Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure
Number of cases reporting postoperative pain	12 months	Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure
Number of cases reporting sinus	12 months	Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure
Number of cases reporting fistula	12 months	Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure
Number of cases reporting tooth mobility	12 months	Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure

Secondary Outcome Measures

Name	Time	Method
Number of cases reporting widening of periodontal membrane space	12 months	Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Number of cases reporting external root resorption	12 months	Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Number of cases reporting internal root resorption	12 months	Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Number of cases reporting furcation involvement	12 months	Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure
Number of cases reporting periapical radiolucency	12 months	Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Trial Locations

Locations (1)

Faculty of Oral and Dental Medicine; 🇪🇬 Cairo, Egypt