Evaluation of the Effectiveness of Calcium Phosphate Containing Desensitizer on Postoperative Sensitivity
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized clinical study, we aim to evaluate the effects of Teethmate Desensitizer
      on postoperative sensitivity when applied underneath the composite restoration by comparing
      it with the negative control group.
    

Detailed description: 
      For the purpose of statistical preliminary analysis, the part related to the comparison of
      the dependent two sample means (t test) was used in the G * power 3.1 program. The power of
      the test was taken as 90%, margin of error 5% and effect size 0.50. The total sample size was
      found to be 44. In this study, the required number of participants was determined to be at
      least 44, since the split-mouth technique in which both the experimental and the control
      groups will be used in each patient, and the number of participants to be included in the
      study was determined as 50 considering the ''drop-outs'' that may occur during the study.
      Then, randomization will be achieved using the blocked randomization technique. Randomization
      will be done on www.sealedenvelope.com website. For blocked randomization, the seed number
      will be 12345 and the block width will be 2.

      After applying to Başkent University Faculty of Dentistry, dental caries are detected as a
      result of the clinical and radiological examination, and female or male patients will be
      selected among the ones who are referred to the Restorative Dentistry Department's clinic for
      treatment. Participation in the study is on a voluntary basis and the participants who accept
      the invitation will have the Informed Consent Form read and signed. If deemed necessary, the
      participants will be given oral hygiene motivation and initiatives will be started after
      their oral hygiene is achieved to a satisfactory level.

      Before starting treatment of individuals diagnosed with caries clinically and radiologically,
      the vitality of the relevant teeth will be measured using a vitalometer (Model D624, Parkell
      Inc, USA). After the opening of 2 cavities in each participant, the cavities will be
      isolated, and Teethmate Desensitizer will be applied randomly to one of the two cavities. In
      order to ensure randomization, the randomization list prepared using the program on
      www.sealedenvelop.com will be put in an opaque envelope. When the application will be made,
      the envelope will be opened. Then, CaOH(Dycal, Dentsply, USA) will be placed in the deepest
      place where the pulp is closest. Restorations will be performed after the matrix system is
      applied when necessary. All cavities one-step self-etch an adhesive (Clearfil SE Bond,
      Kuraray Noritake, Tokyo, Japan) LED light applied according to the user instructions (Ledmax
      Cordless 550 Benlioğlu, Turkey)> 1,500mw / cm2 for 10 seconds polymerized. The teeth will be
      restored using an oblique incremental technique with a composite resin (Filtek Z250, 3M Espe,
      USA). Each layer will be polymerized for 20 sec. Finishing and polishing process will be done
      using diamond finishing burs, tires and polishing discs (Soflex, 3M Espe, USA). Restoration
      will be done by a single operator (LK). After the restoration, patients will be given two
      forms, one for each tooth, where they will record their daily pain levels for a week, and how
      to register on this form will be explained. These forms given to the participants will
      include a Numerical Rating Scale (NRS) with scores between 0-4 and a Visual Analogue Scale
      (VAS) of 0-100mm for 1 week. When patients will be called to the control appointment after a
      week, the forms in which they score the sensitivity level will be taken back. 6 weeks after
      the restorations are applied, the patients will be invited to a control appointment and the
      restorations will be checked. At the first week and sixth week control appointments, the
      restorations will be evaluated by another physician (KY). At the end of the 6 week, the
      vitality will be controlled. During the six-week study, patients will be asked not to use any
      pain medication, and if the participant uses painkillers during the study, the participant
      will be excluded from the study.
    

Intervention name(s): Calcium phosphate desensitizer
Intervention type(s): Drug
Intervention description(s): Calcium phosphate containing desensitizing agent that creates hydroxyappatite
Other intervention name(s): Teethmate Desensitizer
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment