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Completed

NCT Number: NCT01641861

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

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

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Key information

Age range

7 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry , Khon Kaen University

Muang, Changwat Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient 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.
  • Tooth inclusion criteria:
  • 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

  • Patient 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.
  • Tooth exclusion criteria:
  • 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.

Treatment and study plan

Papacarie®

Device

Papacarie® is chemo-mechanical method for caries removal

Other names: Chemo-mechanical removal of decays Agent

Conventional Method

Procedure

caries removal by using rotary instrument.

Primary outcomes

  1. Number of Participants With Treatment Failure

    Time frame: two years

    The dental restorations were evaluated at 6, 12, 18 and 24 months after treatment. Evaluation criteria included the condition of the filling material and presence of secondary caries at the margin of the restorations. The restoration status was re-categorized as a binary outcome: Treatment failure (Yes/No).

Secondary outcomes

  1. Incidence of Secondary Caries

    Time frame: two years

    The restoration teeth were assess by clinical and radiographic examination for detection the recurrent caries.

  2. Number of Participants With Complete Caries Removal

    Time frame: immediately after treatment

    The efficacy of caries removal was evaluated by the visual and tactile criteria. The completeness of caries removal was judged on the basis of clinical criteria involving the inspection of the tooth surfaces using a good light source, dental mirror and explorer. A blunt explorer was used to detect surface roughness by gently stroking across the dentine surfaces and to evaluate the dentine hardness. Complete caries removal was achieved if as remove soft and infected dentine until felt hard and leathery consistency of the dentine surfaces. The tactile criteria include the smooth passage of the blunt explorer and absence of a catch or a "tug-back" sensation.

  3. Levels of Pain and Discomfort

    Time frame: immediately after treatment

    The participants were assessed for the levels of pain and discomfort using the facial visual analogue scale (VAS). The score was recorded in ruler scale from 0-100 millimeters, 0 = no pain and 100 = extreme pain) before treatment with the child sitting on the dental chair and after treatment (completion of carious tissue removal). The difference in the VAS scores before and after treatment was calculated and compared between the two comparison groups.

  4. Time Use for Caries Removal

    Time frame: Immediately while treatment

    The time taken for the removal of carious dentine was recorded using a stopwatch. Recorded time unit is seconds.

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • National Institutes of Health (NIH)

Registry information

Official study title

Study of Papacarie® for Caries Removal.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 17, 2012
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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