Dental Caries
Conditions
Keywords
Indirect Pulp Treatment, Primary Teeth, Biodentine, Calcium Hydroxide, Split-Mouth design
Brief summary
Objective: The study's main purpose is to evaluate and compare the clinical and radiographic outcomes of Biodentine and a light-activated calcium hydroxide based-liner (Ultra-Blend plus®) as indirect pulp treatment (IPT) liners, over the dentin-pulp complex of vital primary molars with carious lesions approaching the pulp. Study design: 80 four-to-eight year-old patients were enrolled from a Mexican University Pediatric Dentistry Clinic. A split-mouth design trial is being conducted in order to compare both IPT interventions on 160 bilateral primary teeth, without signs or symptoms of irreversibly inflamed or degenerative pulp tissue. Teeth were treated and restored with a preformed crown in a single session, and then closely followed-up for 1, 3, 6, 12, 18, and 24 months.
Detailed description
A Split-mouth clinical trial was the design selected. Clinical Procedures: IPT procedures were carried out by three pediatric dentistry residents (E.K.C.G., R.A.V.V., and J.M.A.R.), previously trained in the clinical setting with a pilot sample of 10 similar child patients each. Study participants received local anesthesia and rubber dam isolation, which was disinfected, followed by the remove of the carious peripheral dentin with high speed tungsten-carbide bur # 3, and air-water spray. Then, the soft dentin layer was carefully removed with a sharply-edged sterilized hand excavator, based on tactile and visual standards, leaving only the hard dentin adjacent to the pulp ceiling. The cavity was thoroughly rinsed only with water and then dried with sterilized cotton pellets; no other special disinfection protocol was applied. The next step consisted in the placement of the correspondent liner over the remanent carious dentin layer, following the manufacturers' instructions, and according to the randomly assignment scheme previously described. In the case of the control group, the liner was cured undr 20 seconds of light exposure. All treated molar were restored with stainless steel preformed crowns (3M ESPE) cemented with glass ionomer (Ketac-Cem, 3M ESPE). One week later, the same procedure was repeated in the opposite tooth with the contrary IPT agent.
Interventions
PROCEDUREIndirect Pulp Treatment with Bioactive Dentin Substitute
The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Biodentine and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.
PROCEDUREIndirect Pulp treatment with Calcium hydroxide
The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Ultra-Blend plus, and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.
Sponsors
José Arturo Garrocho Rangel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
4 Years to 8 Years
Healthy volunteers
Yes
Inclusion criteria
* At least one restorable first or second primary molar in each side of the mouth, affected by an occlusal cavitated active caries lesion in deep dentin. * Cooperative patients. * Participants were included in the trial after parental acceptance through a signed informed consent.
Exclusion criteria
* Molars with mobility, spontaneous pain or fistula, and radiographic findings such as a carious lesion with no evidence of residual dentin over the pulp chamber or manifest pulp exposition. * Normally internal root resorption or physiological root resorption less than 1/3. * Presence of periradicular/furcal radiolucent lesions. * Occurrence of a carious pulp exposure and bleeding during the operative procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain. Binary variable (present/absent). | 2 years | Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity to percussion. Binary variable (present/absent). | 2 years | Treated tooth is softly hit with a dental handle mirror. Sensitivity is recorded as a binary variable (present/absent). |
| Abnormal tooth mobility. Binary variable (present/absent). | 2 years | This variable is measured by handling the treated tooth with two fingers. It is a binary variable (present/absent). |
| Soft tissues inflammation. Binary variable (present/absent). | 2 years | This feature is assessed through visual examination of surrounding soft gingival tissues (texture, color, size). It is a binary variable(present/absent) . |
| Periradicular lesions. Binary variable (present/absent). | 2 years | These lesions are observed through radiographic examination. They appear as radiolucencies around the tooth's root (s). It is a binary variable (present/absent) |
| Sensitivity to palpation. Binary variable (present/absent). | 2 years | Treated tooth is softly pressed with a finger. Sensitivity is recorded as a binary variable (present/absent). |
Outcome results
None listed