Not Yet RecruitingPhase 2ACTRN12619000440123

topical agents used in chemo-mechanical removal of caries.

Evaluation of effectiveness of sodium hypochlorite gel and BRIX 3000 in removing caries of primary molars in children.


Sponsor

Damascus University

Enrollment

45 participants

Start Date

May 15, 2019

Study Type

Interventional

Conditions

Summary

Drilling is the most challenging concept in pediatric dentistry, and as modern dentistry represents minimally invasive dentistry. therefore, chemo-mechanical removal of caries is an important way to get rid of all dental caries with preservation of all healthy dental tissues. chemo-mechanical removal of caries is also a method in behavioral management in children as no anesthesia is needed and no drilling instruments are used. The null hypothesis tested is that neither sodium hypochlorite gel nor BRIX 3000 is effective in removing caries of primary molars.


Eligibility

Sex: Both males and femalesMin Age: 4 YearssMax Age: 9 Yearss

Inclusion Criteria5

  • - cooperative children.
  • a- primary molars.
  • b- proximal or occlusal cavitated caries
  • c- no proximity of caries to pulp.
  • d- sufficient dental structure to restore the tooth.

Exclusion Criteria1

  • Children who have any allergic reaction to the components of BRIX 3000

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Interventions

children included in the trial will be divided into three groups: Group A: Sodium hypochlorite gel. Group B: BRIX 3000 gel. Group C: conventional drilling. the method of application of chemo-mec

children included in the trial will be divided into three groups: Group A: Sodium hypochlorite gel. Group B: BRIX 3000 gel. Group C: conventional drilling. the method of application of chemo-mechanical gels: teeth will be selected randomly and they should be primary molars which have a cavitated proximal or occlusal caries with no proximity to pulp. The procedure will be performed without anesthesia, the teeth will be dried, following the principles of Atraumatic Restorative Treatment (ART). and the gel will be applied by a dentist in an amount of half a grain of rice as mentioned by the manufacturer of BRIX 3000. the application will be with a #2 dentin excavator, leaving it to act for 2 minutes , following the BRIX 3000 manufacturer’s instructions.The infected tissue was then removed through curettage, first at the surrounding walls, using a #2 dentin excavator followed by pulpal wall. the cavity will be washed and dried thorougly. then, caries detector dye will be applied with a microbrush to detect any carious dentin still present. if any carious tissues will be detected, reapplying of the gel will be considered. A timer will be switched on at the moment of gel application and it will be switche off whenever all caries will be removed to record time needed to remove caries in minutes. The whole application will be done by a pedodontist who is available to help researchers and he will monitor the whole procedure. Immediately after the treatment, the child will be questioned about the discomfort with the performed procedure using the Wong-Baker face scale. The child will be instructed to point to the picture that represents his level of discomfort after the following question: what did you feel during treatment? All teeth will be restored with restorations according to the remaining dental structure.


Locations(1)

Damascus, Syrian Arab Republic

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