Comparison Between Egyptian MTA, Biodentine Versus Calcium Hydroxide as Indirect Pulp Capping Materials In Permanent Teeth

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22-45
SponsorCairo University

About this trial

Compare the clinical performance and patient satisfaction of Egyptian MTA, Biodentine versus Calcium Hydroxide as indirect pulp capping materials in permanent teeth

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adult patients aged 22: 45 years old.

Males or females.

Patients with vital teeth with deep carious lesions.

Patients in good general health.

Disqualifiers

Patients with systemic diseases.

Patients with known allergic or adverse reaction to the tested materials.

Patients with bad oral hygiene.

Patient who frequently use analgesic or any drugs that could mask the pain.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Egyptian MTA

    Drug

    * Complete caries removal from the cavity. * The liquid of Egyptian MTA (Toothmate) will be mixed with powder according to the manufacturers' instructions. * The capping materials will be placed with the passive application on the deepest part of the cavity. Only light pressure will be applied on the MTA mixture using a wet cotton pellet to ensure adaptation of the material onto the dentin. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

  • Biodentine

    Drug

    * Complete caries removal from the cavity. * Gently tapping a capsule of Biodentine (Septodont) on a hard surface to loosen the powder, then opening the capsule, Detaching a single-dose container of liquid and gently tapping on the sealed cap to force all the liquid down the container, Twisting cap to open, Then Pouring 5 drops from the single-dose container into the capsule, Then Closing the capsule and Placing it on a mixing device for 30 seconds, Then Collecting Biodentine with the instrument supplied in the box. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

  • Calcium Hydroxide (Ca(OH)2)

    Drug

    * Complete caries removal from the cavity. * According to the manufacturers' instructions, Dispensing equal volumes of base and catalyst pastes on the parchment paper pad provided. Using a Dycal (Dentsply) Liner applicator, stirring immediately to mix thoroughly until a uniform color is achieved, complete mixing occurs within 10 seconds, using the ball-pointed Dycal Liner applicator or similar instrument, the mix will be placed directly on the cavity. * The capping materials will be placed with the passive application on the deepest part of the cavity. * A light-cured glass ionomer cement base will be applied in the cavity . * Selective enamel etching will be applied on enamel only. * The one-bottle universal adhesive system bond will be applied on enamel and dentine. * A Nano hybrid composite resin material will then be incrementally inserted into the cavities.

Treatment groups

35 Participants
are divided into 3 treatment groups
Group A: Egyptian MTAExperimental treatment 1 intervention
Group B: BiodentineExperimental treatment 1 intervention
Group C: Calcium HydroxideActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical assessment of treatment success

Pulp response to different stimuli by thermal and electrical pulp tests. When tooth normally responds to thermal and electrical pulp tests = success When tooth doesn't respond to thermal and electrical pulp tests = failure

Time frame
T( Time) T0( base line)= one week after , T2= 3 months , T3= 6 months

Secondary outcomes

1

Clinical assessment of pain

Patient reported outcome measures by visual analogue scale visual analogue scale is used to describe the pain by patients themselves in scores as ( 0: no pain ) \& (7-10 : Severe pain)

Time frame
T( time) T0( baseline )= 1 week after, T1= 3 months, T2= 6 months
2

Patient satisfaction with the treatment

Patient reported outcome measure by 4- point likert scale 4- point likert scale used to describe patient satisfaction with the treatment as " (a) yes, very satisfied" \& " (d) not all satisfied"

Time frame
T( time) T0= 1 week after, T1= 3 months , T2= 6 months

Other outcomes

Sponsors and contacts

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