Indirect Pulp Treatment in Primary Molars (RCT)

Evaluation of Resin Modified Glass Ionomer Liner (Vitrebond™) Versus Calcium Hydroxide as Indirect Pulp Treatment Material Used in Deep Carious Lesions in Primary Molars: A Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Dental Caries
• Intervention / Treatment: Drug: Indirect pulp treatment using Dycal (TM); Drug: Indirect pulp treatment using Vitrebond (TM )

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 Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11553
    • Faculty of Oral and Dental Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

In compliance with AAPD, 2017 guidelines for pulp therapy "IPT is indicated in a primary tooth with no pulpitis or with reversible pulpitis when the deepest carious dentin is not removed to avoid a pulp exposure. The pulp is judged by clinical and radiographic criteria to be vital and able to heal from the carious insult"

In addition to:

I-Subjects:

1. Medically free children, their parent(s) accepts to sign the informed consent.
2. Age range from 4-8 years.

II-Molars:

1. Presence of at least 1 primary molar with deep carious lesion extending to more than one half of the dentin on radiographic examination (to make the trial regardless of number of carious molars).
2. Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
3. Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria:

I-Subjects:

1. Uncooperative children.
2. Parents unable to attend follow up visits (even after explaining the importance of recall visits).

II-Molars:

1. History of spontaneous pain (to exclude reversible pulpitis).
2. Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth).
3. Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: IPT using Dycal (TM ); Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal	Drug: Indirect pulp treatment using Dycal (TM); Partial caries removal and protection of the dental pulp with biocompatible material; Other Names: Indirect pulp capping; Drug: Indirect pulp treatment using Vitrebond (TM ); Partial caries removal and protection of the dental pulp with biocompatible material; Other Names: Indirect pulp capping
Experimental: IPT using Vitrebond (TM ); Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal	Drug: Indirect pulp treatment using Dycal (TM); Partial caries removal and protection of the dental pulp with biocompatible material; Other Names: Indirect pulp capping; Drug: Indirect pulp treatment using Vitrebond (TM ); Partial caries removal and protection of the dental pulp with biocompatible material; Other Names: Indirect pulp capping

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Principal Investigator: Shereen E Taha, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): August 1, 2017
• Study Completion (Actual): July 1, 2018

Study Registration Dates

• First Submitted: August 18, 2018
• First Submitted That Met QC Criteria: December 7, 2018
• First Posted (Actual): December 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: Children; indirect pulp; primary; calcium hydroxide; resin modified glass ionomer
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: CEBD-CU-2014-11-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: final results

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes