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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
80
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.
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.
Pain. Binary variable (present/absent).
Pain is assessed through interrogatory. It is a binary variable (pain present or pain absent)
Time frame: 2 years
Sensitivity to percussion. Binary variable (present/absent).
Treated tooth is softly hit with a dental handle mirror. Sensitivity is recorded as a binary variable (present/absent).
Time frame: 2 years
Abnormal tooth mobility. Binary variable (present/absent).
This variable is measured by handling the treated tooth with two fingers. It is a binary variable (present/absent).
Time frame: 2 years
Soft tissues inflammation. Binary variable (present/absent).
This feature is assessed through visual examination of surrounding soft gingival tissues (texture, color, size). It is a binary variable(present/absent) .
Time frame: 2 years
Periradicular lesions. Binary variable (present/absent).
These lesions are observed through radiographic examination. They appear as radiolucencies around the tooth's root (s). It is a binary variable (present/absent)
Time frame: 2 years
Sensitivity to palpation. Binary variable (present/absent).
Treated tooth is softly pressed with a finger. Sensitivity is recorded as a binary variable (present/absent).
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.