A randomized control clinical trial to evaluate the efficacy of 2 bio resorbable matrices in apexification procedure.

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2017/07/009029
• Date of registration: 12-07-2017
• Prospective Registration: No
• Primary sponsor: Aysha Siddiqui
• Public title: A randomized control clinical trial to evaluate the efficacy of 2 bio resorbable matrices in apexification procedure.
• Scientific title: To evaluate and compare apexification procedure with and without the use of extra radicular matrices.
• Date of first enrolment: 10-02-2015
• Target sample size: 33
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=14279
• Study type: Interventional
• Study design: Randomized, Parallel Group, Active Controlled Trial; Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded
• Phase: Phase 2

Countries of recruitment

India

Contacts

• Name: Dr Richha Khanna
• Affiliation: King Georges Medical University

• Name: Aysha Siddiqui
• Affiliation: King Georges Medical University

Key inclusion & exclusion criteria

Inclusion criteria: Child patients with non vital young permanent teeth with open apices, secondary to caries or trauma, indicated for endodontic treatment.
Exclusion criteria: Patients with known allergy to any of the dental materials to be used. Tooth with root fracture, unrestorable remaining crown structure, internal or external root resorption, systemic conditions, syndromes and congenital malformation.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Non vital permanent teeth in otherwise healthy dental child patients

Intervention(s)

Intervention1: Platelet-rich fibrin (PRF): Platelet-rich fibrin (PRF) or leucocyte- and platelet-rich fibrin (L-PRF) is a second-generation PRP where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue and is used as a tissue-engineering scaffold for endodontics.
Intervention2: Hydroxyapatite bone graft.: Sterile Synthetic Nanocrystalline Hydroxyapatite Bone Graft.Synthetically prepared in powder/ granule form with particle size ranging from 200-300 and 600-700 microns.
Control Intervention1: No barrier used: conventional method of not not using any extra radicular barrier

Primary Outcome(s)

Complete control and resolution of signs and symptoms of pain, swelling, fistula, mobility and absence of tenderness on percussion.Timepoint: Follow up at 6 and 12 months

Secondary Outcome(s)

Absence of Periapical bone loss, radiographic healing of periapical lesion.Timepoint: 12 months

Secondary ID(s)

NIL

Source(s) of Monetary Support

King Georges Medical University, Lucknow, Uttar Pradesh.

Ethics review

Status: Approved
Approval date: 12/02/2016
Contact:

Ethics committee, Research Cell, KGMU