A Comparative Study of Papacarie® and the Conventional Method for Dental Caries Treatment

NCT ID: NCT01641861

Last Updated: 2016-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 488 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2015-09-30

Brief Summary

The purpose study are to evaluate the efficacy of Papacarie® for caries removal in comparison to the conventional drilling method.

Detailed Description

Dental caries in children continues to affect a significant portion of the world population, especially in developing countries. There are many techniques used for dental caries treatment. The conventional method is to remove caries and prepare the cavity using dental burs. Disadvantages of this method; however, include the patients' repulsion of drilling, and possible thermal changes on tooth surface that may have an effect on the dental pulp tissues. In addition, the drilling technique frequently requires local anesthesia injections and sometimes results in the removal of sound tooth tissues. To overcome these problems and preserve the healthy dental tissues, the chemo-mechanical caries removal method was developed. The advantage by chemomechanical caries removal include less traumatic, less need local anesthesia, reduced chance of dental pulp exposure. And also it could be benefit to medical compromised patients.

Papacarie® is a new chemo-mechanical technique for caries removal with few published research and case reports. A randomized controlled trial is therefore needed to determine the efficacy of its use in general population. The aims of this study are to evaluate the efficacy of a chemo-mechanical system (Papacarie®) for caries removal in comparison to the conventional drilling method.

Conditions

Dental Caries; Secondary Dental Caries; Personal Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control arm

control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.

Group Type: EXPERIMENTAL

Conventional method

Intervention Type: PROCEDURE

caries removal by using rotary instrument.

Intervention arm

Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.

Group Type: EXPERIMENTAL

Papacarie®

Intervention Type: DEVICE

Papacarie® is chemo-mechanical method for caries removal

Interventions

Papacarie®

Papacarie® is chemo-mechanical method for caries removal

Intervention Type: DEVICE

Conventional method

caries removal by using rotary instrument.

Intervention Type: PROCEDURE

Other Intervention Names

Chemo-mechanical removal of decays Agent

Eligibility Criteria

Inclusion Criteria

• Child is between 7-8 years of ages (at date of enrollment) with at least one active caries lesion in second primary molar tooth with distinct dentine involvement requiring restoration
• Child is in good general health and has no existing health condition that may interfere with treatment such as asthma, tuberculosis, rheumatic fever/ congenital heart diseases, jaundice, juvenile diabetes, haemophilia, thalassemia, leukemia, anemia , HIV , allergy to any drug, and epilepsy.
• Second primary molar tooth with one active caries lesion with distinct dentine involvement requiring restoration using the World Health Organization Criteria.
• Tooth with isolated occlusal caries and caries extended on further than two-third of the dentine layer, which can be restoration as a Class I restoration.
• Carious cavity must be large enough so that the hand instruments can be operated.
• Tooth is vital without pathological process assessed clinically and radiographically.

Exclusion Criteria

• Child whose parent does not give informed consent.
• Child who are unwilling to undergo the dental treatment.
• Child who has a known allergy to the ingredients contained in dental anesthesia, Papacarie® or glass-ionomer filling material.
• Having extensive dental caries which may require pulp treatment.
• Tooth with a pathological process of the dental tissue other than caries that could affect the treatment, such as tooth development disorders or adjacent soft tissue lesion.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role: collaborator

Khon Kaen University

OTHER

Sponsor Role: lead

Responsible Party

Kemporn Kitsahawong

Associated Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kemporn Kitsahawong, DDS., MSc.

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, Khon Kaen University

Locations

Faculty of Dentistry , Khon Kaen University

Muang, Changwat Khon Kaen, Thailand

Countries

Thailand

References

Kitsahawong K, Seminario AL, Pungchanchaikul P, Rattanacharoenthum A, Sutthiprapaporn P, Pitiphat W. Efficacy of chemo-mechanical caries removal: a 24-month randomized trial. Front Oral Health. 2024 Dec 3;5:1458530. doi: 10.3389/froh.2024.1458530. eCollection 2024.

Reference Type: DERIVED

PMID: 39697785 (View on PubMed)

Other Identifiers

D43TW007768

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HE542161

Identifier Type: -

Identifier Source: org_study_id