Indirect Pulp Treatment in Primary Molars

NCT03770871 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: CEBD-CU-2014-11-3
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries

Keywords

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Number of cases reporting external root resorption

  12 months

• Number of cases reporting internal root resorption

  12 months

• Number of cases reporting furcation involvement

  12 months

• Number of cases reporting widening of periodontal membrane space

  12 months

• Number of cases reporting periapical radiolucency

  12 months

Study Arms (2)

IPT using Dycal (TM )

ACTIVE COMPARATOR

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

Drug: Indirect pulp treatment using Dycal (TM); Drug: Indirect pulp treatment using Vitrebond (TM )

IPT using Vitrebond (TM )

EXPERIMENTAL

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

Drug: Indirect pulp treatment using Dycal (TM); Drug: Indirect pulp treatment using Vitrebond (TM )

Interventions

Indirect pulp treatment using Dycal (TM) DRUG

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

Also known as: Indirect pulp capping

IPT using Dycal (TM ); IPT using Vitrebond (TM )

Indirect pulp treatment using Vitrebond (TM ) DRUG

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

Also known as: Indirect pulp capping

IPT using Dycal (TM ); IPT using Vitrebond (TM )

Eligibility Criteria

• Age: 4 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Oral and Dental Medicine

Cairo, 11553, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Shereen E Taha, Professor

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher assisstant

Model Details: Parallel group with 1:1 allocation ratio

Study Record Dates

• First Submitted: August 18, 2018
• First Posted: December 10, 2018
• Study Start: August 1, 2016
• Primary Completion: August 1, 2017
• Study Completion: July 1, 2018
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)