Clinical trial NCT02799927: Comparison Between Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth
Official title: A Split-mouth Trial Comparing Biodentine and Calcium Hydroxide in the Indirect Pulp Treatment on Primary Teeth
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Dental Caries
Keywords: Indirect Pulp Treatment
Primary Teeth
Biodentine
Calcium Hydroxide
Split-Mouth design
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 80
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain. Binary variable (present/absent).
timeFrame: 2 years
Secondary outcomes:
measure: Sensitivity to percussion. Binary variable (present/absent).
timeFrame: 2 years
measure: Abnormal tooth mobility. Binary variable (present/absent).
timeFrame: 2 years
measure: Soft tissues inflammation. Binary variable (present/absent).
timeFrame: 2 years
measure: Periradicular lesions. Binary variable (present/absent).
timeFrame: 2 years
measure: Sensitivity to palpation. Binary variable (present/absent).
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric Dentistry Postgraduate Program
name: María S Ruiz, M. Sc.
role: STUDY_CHAIR
References:
citation: Al-Zayer MA, Straffon LH, Feigal RJ, Welch KB. Indirect pulp treatment of primary posterior teeth: a retrospective study. Pediatr Dent. 2003 Jan-Feb;25(1):29-36.
citation: Casagrande L, Bento LW, Rerin SO, Lucas Ede R, Dalpian DM, de Araujo FB. In vivo outcomes of indirect pulp treatment using a self-etching primer versus calcium hydroxide over the demineralized dentin in primary molars. J Clin Pediatr Dent. 2008 Winter;33(2):131-5. doi: 10.17796/jcpd.33.2.82r1tp71x75m5345.
citation: Fernandes JM, Massoni AC, Ferreira JM, Menezes VA. Use of calcium hydroxide in deep cavities of primary teeth. Quintessence Int. 2013;44(6):417-23. doi: 10.3290/j.qi.a29503.
citation: Kim J, Song YS, Min KS, Kim SH, Koh JT, Lee BN, Chang HS, Hwang IN, Oh WM, Hwang YC. Evaluation of reparative dentin formation of ProRoot MTA, Biodentine and BioAggregate using micro-CT and immunohistochemistry. Restor Dent Endod. 2016 Feb;41(1):29-36. doi: 10.5395/rde.2016.41.1.29. Epub 2016 Jan 4.
citation: Petrou MA, Alhamoui FA, Welk A, Altarabulsi MB, Alkilzy M, H Splieth C. A randomized clinical trial on the use of medical Portland cement, MTA and calcium hydroxide in indirect pulp treatment. Clin Oral Investig. 2014;18(5):1383-9. doi: 10.1007/s00784-013-1107-z. Epub 2013 Sep 17.
citation: Trairatvorakul C, Sastararuji T. Indirect pulp treatment vs antibiotic sterilization of deep caries in mandibular primary molars. Int J Paediatr Dent. 2014 Jan;24(1):23-31. doi: 10.1111/ipd.12022. Epub 2013 Jan 24.