Clinical trial NCT03785730: Non-restorative Cavity Control in Anterior Cavitated Caries Lesion of Primary Teeth
Official title: Impact of Non-restorative Cavity Control on Proximal Carious Lesions of Anterior Primary Teeth on the Tooth Survival and Patient-centered Outcomes (CEPECO 2) - Study Protocol for a Non-inferiority Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Universidade Ibirapuera
Sponsor class: OTHER
First posted: 2018-12-24
Enrollment: 148
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on proximal carious lesion in anterior primary teeth, as well as the impact of these treatments on patient-centered outcomes. Methods: A randomized clinical trial with two parallels arms (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC through cavity enlargement using metallic sandpaper. The primary outcome will be tooth survival after 6, 12, 18, and 24 months. The duration and the cost of dental treatments will be considered for the estimation of the cost-effectiveness of the evaluated treatments. The discomfort reported by the participants will be measured after each treatment using the FIS scale. The participants' satisfaction and perception of the parents/legal guardians will be evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and Long-Rank test will be used for comparison between the two groups. All the variables will be modeled by Cox regression with shared fragility. Significance will be considered at 5%.

Detailed description: This non-inferiority randomized controlled clinical trial, with two parallel groups with 1:1 allocation ratio, was approved by the Research Ethics Committee of Universidade Ibirapuera (UNIB). The other centers involved are considered co-participants (Centro Universitário do Norte - Uninorte , Centro Universitário Uninovafapi - UNINOVAFAPI, and School of Dentistry from the University of Sao Paulo - FOUSP). Children aged 3 to 6 years with at least one proximal cavitated lesion on anterior primary teeth will be selected from the Clinical Pediatric Research Center. Teeth will be randomly allocated to selective removal of carious tissue and resin composite restoration (RCR) or NRCC. Tooth survival after two years of follow-up will be the primary outcome and cost-effectiveness, satisfaction, and discomfort reported by participants and parents/guardians' perception will be the secondary outcomes. Only patients who fulfill the eligibility criteria will be included in the study after the legal guardians sign the informed consent form and the child consents to participate in the study.

Eligibility criteria: Inclusion Criteria:

* Children will be included that have at least one anterior tooth with carious lesion cavitated affecting the proximal surface.

Exclusion Criteria:

* Patients will be excluded with special needs, using orthodontics devices and/or systemic diseases which may affect the oral cavity.
* Also, teeth with lesions affecting more than one third of the buccal/lingual surfaces, with previous history of dental trauma, presenting pulp exposure, spontaneous pain, pathological mobility, presence of abscess or fistula next to the tooth, teeth with restorations, developmental enamel defects or physiological mobility (exfoliation) will be excluded.

Primary outcomes:
measure: Tooth survival by clinical assessment
timeFrame: 24 months
Secondary outcomes:
measure: Discomfort regarding the treatment options by a Face image scale (FIS)
timeFrame: Immediately after treatment
measure: Cost-effectiveness analysis
timeFrame: 24 months.
measure: Perception of parents / guardians evaluated through questionnaire
timeFrame: Prior to treatment, immediately after and 6 months later.
measure: Satisfaction of children: questionnaire
timeFrame: After 6 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Tamara Kerber Tedesco
state: SP
Study officials:
References:
citation: Bianchi RMD, Pascareli-Carlos AM, Floriano I, Raggio DP, Braga MM, Gimenez T, Holanda MC, da Silva GS, de Natal KH, Tedesco TK. Impact of non-restorative cavity control on proximal carious lesions of anterior primary teeth on the tooth survival and patient-centered outcomes (CEPECO 2): study protocol for a non-inferiority randomized clinical trial. BMC Oral Health. 2021 Mar 31;21(1):167. doi: 10.1186/s12903-021-01524-0.