Indirect Pulp Treatment in Primary Molars

Dental Caries Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03770871
• Other study ID #: CEBD-CU-2014-11-3
• Status: Completed
• Phase: Phase 4
• Start date: August 2016
• Est. completion date: July 2018

Study information

• Verified date: August 2019
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 2018
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 8 Years

Eligibility

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).

Related Conditions & MeSH terms

• Dental Caries

Intervention

Drug:
• Indirect pulp treatment using Dycal (TM)
Partial caries removal and protection of the dental pulp with biocompatible material
• Indirect pulp treatment using Vitrebond (TM )
Partial caries removal and protection of the dental pulp with biocompatible material

Locations

Country	Name	City	State
Egypt	Faculty of Oral and Dental Medicine	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases reporting postoperative pain	Presence of postoperative pain following dental treatment through patient questionnaire as a sign of clinical failure	12 months
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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