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Indirect Pulp Treatment in Primary Molars (RCT)

Primary Purpose

Dental Caries

Status

Completed

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Indirect pulp treatment using Dycal (TM)

Indirect pulp treatment using Vitrebond (TM )

About this trial

This is an interventional treatment trial for Dental Caries focused on measuring indirect pulp, primary, calcium hydroxide, resin modified glass ionomer, Children

Eligibility Criteria

4 Years - 8 Years (Child)All SexesAccepts Healthy Volunteers

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:

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

II-Molars:

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).
Clinically: Normal mobility and normal appearance of gingiva (vital teeth).
Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT).

Exclusion criteria:

I-Subjects:

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

II-Molars:

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

Sites / Locations

Faculty of Oral and Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

IPT using Dycal (TM )

IPT using Vitrebond (TM )

Arm Description

Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal

Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal

Outcomes

Primary Outcome Measures

Number of cases reporting postoperative pain

Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure

Number of cases reporting swelling

Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure

Number of cases reporting sinus

Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure

Number of cases reporting fistula

Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure

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

Secondary Outcome Measures

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

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

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

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

Number of cases reporting periapical radiolucency

Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Full Information

NCT ID

NCT03770871

First Posted

August 18, 2018

Last Updated

August 28, 2019

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT03770871

Brief Title

Indirect Pulp Treatment in Primary Molars

Acronym

RCT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Completed

Study Start Date

August 2016 (Actual)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

July 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dental Caries

Keywords

indirect pulp, primary, calcium hydroxide, resin modified glass ionomer, Children

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Model Description

Parallel group with 1:1 allocation ratio

Masking

ParticipantInvestigatorOutcomes Assessor

Masking Description

Double blinded

Allocation

Randomized

Enrollment

88 (Actual)

8. Arms, Groups, and Interventions

Arm Title

IPT using Dycal (TM )

Arm Type

Active Comparator

Arm Description

Indirect pulp treatment; IPT using Dycal (TM ); (2 paste system) by partial caries removal

Arm Title

IPT using Vitrebond (TM )

Arm Type

Experimental

Arm Description

Indirect pulp treatment; IPT using Vitrebond (TM );(powder and liquid) by partial caries removal

Intervention Type

Drug

Intervention Name(s)

Indirect pulp treatment using Dycal (TM)

Other Intervention Name(s)

Indirect pulp capping

Intervention Description

Partial caries removal and protection of the dental pulp with biocompatible material

Intervention Type

Drug

Intervention Name(s)

Indirect pulp treatment using Vitrebond (TM )

Other Intervention Name(s)

Indirect pulp capping

Intervention Description

Partial caries removal and protection of the dental pulp with biocompatible material

Primary Outcome Measure Information:

Title

Number of cases reporting postoperative pain

Description

Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure

Time Frame

12 months

Title

Number of cases reporting swelling

Description

Presence of postoperative swelling following dental treatment through visual examination using hand mirror as a sign of clinical failure

Time Frame

12 months

Title

Number of cases reporting sinus

Description

Presence of sinus following dental treatment through visual examination using hand mirror as a sign of clinical failure

Time Frame

12 months

Title

Number of cases reporting fistula

Description

Presence of fistula following dental treatment through visual examination using hand mirror as a sign of clinical failure

Time Frame

12 months

Title

Number of cases reporting tooth mobility

Description

Presence of abnormal tooth mobility following dental treatment through tactile examination using two hand mirrors as a sign of clinical failure

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Number of cases reporting external root resorption

Description

Occurrence of pathological external root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Time Frame

12 months

Title

Number of cases reporting internal root resorption

Description

Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Time Frame

12 months

Title

Number of cases reporting furcation involvement

Description

Occurrence of pathological internal root resorption following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Time Frame

12 months

Title

Number of cases reporting widening of periodontal membrane space

Description

Occurrence of widening of periodontal membrane space following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Time Frame

12 months

Title

Number of cases reporting periapical radiolucency

Description

Occurrence of periapical radiolucency following dental treatment through parallel periapical radiographic examination as a sign of radiographic failure

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

8 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: Medically free children, their parent(s) accepts to sign the informed consent. Age range from 4-8 years. II-Molars: 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). Clinically: Normal mobility and normal appearance of gingiva (vital teeth). Radiographically: Normal roots without physiological resorption, normal lamina dura and normal periodontal membrane space (indicated for IPT). Exclusion criteria: I-Subjects: Uncooperative children. Parents unable to attend follow up visits (even after explaining the importance of recall visits). II-Molars: History of spontaneous pain (to exclude reversible pulpitis). Clinically: Presence of swelling, sinus, fistula or tooth mobility (to exclude non vital teeth). Radiographically: Presence of radiolucent lesions at furcation or periapical region or external or internal resorption (to exclude teeth not indicated for IPT).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shereen E Taha, Professor

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Faculty of Oral and Dental Medicine

City

Cairo

ZIP/Postal Code

11553

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

final results

Learn more about this trial

Indirect Pulp Treatment in Primary Molars

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