a clinical trial to study the effects of three different type of restorative materials like Biodentine, MTA and Calcium phosphate cement in patients with infection in newly erupted teeth with incomplete root formation.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2018/03/012737
• Date of registration: 22-03-2018
• Prospective Registration: No
• Primary sponsor: DrAnjali Yadav
• Public title: a clinical trial to study the effects of three different type of restorative materials like Biodentine, MTA and Calcium phosphate cement in patients with infection in newly erupted teeth with incomplete root formation.
• Scientific title: A comparative evalution of MTA, biodentine and calcium phosphate cement in single visit apexification procedure for non-vital immature permanent teeth-a randomized controlled trial.
• Date of first enrolment: 28-03-2017
• Target sample size: 78
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=18160
• Study type: Interventional
• Study design: Randomized, Parallel Group, Multiple Arm Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded
• Phase: N/A

Countries of recruitment

India

Contacts

• Name: Dr Rakesh Kumar Chak
• Affiliation: King George Medical University

• Name: Dr Richa Khanna
• Affiliation: King George Medical University

Key inclusion & exclusion criteria

Inclusion criteria: 1.patients presenting with a non vital immature permanent teeth as a consequence of trauma or dental caries.

2. Non vital permanent teeth with radiographic evidence of immature root end developement.

3.Restorable non vital immature permanent teeth.
Exclusion criteria: 1.Immature non vital permanent teeth presenting with signs/symptoms of internal/internal resorption, moderate to severe mobility, peridontol bone loss, lack of restorability.

2.Immature non-vital permanent teeth with associated developmental abnormalities.

3.Patients with history of systemically debilitating diseases like uncontrolled diabetes, immunosuppression, severe asthma etc.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- immature permanent teeth

Intervention(s)

Intervention1: Biodentine: Biodentine in putty like consistency carried to the root end of the immature permanent teeth.

Intervention2: calcium phosphate: calcium phosphate cement mixture is carried to root end of the immature permanent tooth.
Control Intervention1: MTA (Mineral Trioxide Aggregate)

: MTA paste in putty like consistency will be delivered to root end of immature permanent teeth.

Primary Outcome(s)

primary outcome will be apex formationTimepoint: primary outcome will be apex formation

Secondary Outcome(s)

symptomatic reliefTimepoint: with in a week

Secondary ID(s)

NIL

Source(s) of Monetary Support

Department of Pediatric and Preventive Dentistry, Faculty of Dental Sciences King George Medical University, Lucknow 226003

Ethics review

Status: Approved
Approval date: 30/12/2016
Contact:

institutional ethical committee