Partial or Complete Excavation of Deep Caries in Primary Molars

NCT04614285 | Unknown

• 1 other identifier: Dnr. 2018/743-31/1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Dental caries; Dental treatment; Pediatric dentistry; Practice-based research network; Randomized clinical trial

Outcome Measures

Primary Outcomes (2)

• Success

  Success will be measured by assessing if the restoration is in place (i.e. tooth in place vs. tooth lost) and without comment.

  24 months

• Tooth survival

  Tooth survival will be measured by assessing tooth exfoliation without causing pain or infection.

  24 months

Secondary Outcomes (1)

• Decision-making Questionnaire

  24 months

Study Arms (2)

Partial excavation

EXPERIMENTAL

The treatment will be performed after applying local anesthetic according to individual needs. The intervention group will receive partial removal of the carious lesion; In the inner part of the lesion, the caries removal will be limited to reach leathery or slightly soft dentin by probing. The restorations will be placed according to evidence based methods and the material used according to the operators material of choice.

Procedure: Partial excavation

Complete excavation

ACTIVE COMPARATOR

The treatment will be performed after applying local anesthetic according to individual needs. The control group will receive the same treatment procedure as the intervention group, but the excavation procedure will include total removal of the carious tissue. The total caries removal will be ensured with hardness on probing and the visual examination. Photographs will be used as benchmark.

Procedure: Partial excavation

Interventions

Partial excavation PROCEDURE

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.

Also known as: Selective excavation, Incomplete excavation

Complete excavation; Partial excavation

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children in the age of 3-8 years, with one or more primary molar teeth in a need of a restoration due to a moderate depth of carious lesion;
• caries lesion diagnosed into dentin on radiographs though not exceeding the inner third of the dentin
• caries lesion diagnosed visually with a cavity into dentin.

You may not qualify if:

• Children with behaviour management problems.
• Teeth with pulpal symptoms
• Teeth expected to exfoliate within the next 18 months

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Division of Orthodontics and Pediatric Dentistry, Department of Dental Medicine, Karolinska Institutet, Sweden

Huddinge, Stockholm County, 141 04, Sweden

RECRUITING

Related Publications (5)

• Franzon R, Guimaraes LF, Magalhaes CE, Haas AN, Araujo FB. Outcomes of one-step incomplete and complete excavation in primary teeth: a 24-month randomized controlled trial. Caries Res. 2014;48(5):376-83. doi: 10.1159/000357628. Epub 2014 Apr 8.

  PMID: 24732081 BACKGROUND

• Griffin SO, Oong E, Kohn W, Vidakovic B, Gooch BF; CDC Dental Sealant Systematic Review Work Group; Bader J, Clarkson J, Fontana MR, Meyer DM, Rozier RG, Weintraub JA, Zero DT. The effectiveness of sealants in managing caries lesions. J Dent Res. 2008 Feb;87(2):169-74. doi: 10.1177/154405910808700211.

  PMID: 18218845 BACKGROUND

• Oong EM, Griffin SO, Kohn WG, Gooch BF, Caufield PW. The effect of dental sealants on bacteria levels in caries lesions: a review of the evidence. J Am Dent Assoc. 2008 Mar;139(3):271-8; quiz 357-8. doi: 10.14219/jada.archive.2008.0156.

  PMID: 18310731 BACKGROUND

• Ricketts D, Lamont T, Innes NP, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013 Mar 28;(3):CD003808. doi: 10.1002/14651858.CD003808.pub3.

  PMID: 23543523 RESULT

• Schwendicke F, Dorfer CE, Paris S. Incomplete caries removal: a systematic review and meta-analysis. J Dent Res. 2013 Apr;92(4):306-14. doi: 10.1177/0022034513477425. Epub 2013 Feb 8.

  PMID: 23396521 RESULT

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Göran Dahllöf, Professor

  Department of Dental Medicine, Karolinska Institutet, Sweden

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Annika M Julihn, DDS, PhD

CONTACT

+46-70-7941697; annika.julihn@ki.se

Georgios Tsilingaridis, DDS, PhD

CONTACT

georgios.tsilingaridis@ki.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, PhD

Model Details: The study has a prospective multi-center, two arms randomized controlled clinical trial design.

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: November 3, 2020
• Study Start: March 1, 2019
• Primary Completion: November 30, 2020
• Study Completion: November 1, 2022
• Last Updated: November 25, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)