MedTrace Logo

Partial or Complete Excavation of Deep Caries in Primary Molars

NCT04614285 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2020-11-25

No results posted yet for this study

Summary

Background: The traditional approach of carious lesions with risk for progression has has been to excavate all infected and demineralised tissue before placement of the restoration. In primary teeth, treatment of deep carious lesions is associated with significant risk of pulp lesions and postoperative complications and thus the risk of the teeth being lost. During the past decade, more focus has been on biological methods for caries excavating of deep dentin lesions. An overview comparing different biological methods such as partial or stepwise excavation of deep dentin caries in primary teeth shows that they work as well as traditional methods performing complete caries excavation but have the benefits of reducing the risk of iatrogenic pulp damage \[1-3\].

Our primary hypothesis is that there is no difference in tooth or filling survival after partial caries excavation compared to complete caries excavation in primary molars.

The secondary hypothesis is that the therapist's knowledge, experience and treatment attitudes and choices are not affected by a participation in the study.

Conditions

  • Dental Caries in Children

Interventions

PROCEDURE

Partial excavation

Operators sign up for participation at the homepage of Center for Pediatric Oral Health Research (ABC). The study will be carried out in a Practice-Based Research Network setting. All practitioners interested in participating in the study will get access to an online information about their participation after they signed up. The participation starts by answering a questionnaire on their treatment attitudes and experiences. Patients will be identified during the routine dental examination. If a carious lesion in the primary molars is detected and in a need of a restoration, the children and parents will be asked to participate in the study. The parents receive information about the study and give their consent. Allocation into treatment groups will be performed by random assignment by the homepage of ABC. After the study is finished the participating dentist will be asked to answer the same questionnaire to investigate the effect of the participation on the operators attitude.

Sponsors & Collaborators

Principal Investigators

  • Göran Dahllöf, Professor · Department of Dental Medicine, Karolinska Institutet, Sweden

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2020-11-30
Completion
2022-11-01

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04614285 on ClinicalTrials.gov