Regenerative Ability of Immature Necrotic Permanent Teeth Using Different Scaffolds

NCT06693739 | Active Not Recruiting

• 1 other identifier: 072030
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare effect of different scaffolds on the regenerative potential of young permanent immature teeth with necrotic pulp. The main question it aims to answer is: is there difference in regenerative potential using Hyaluronic acid and platelets rich fibrin as scaffolds in permanent immature teeth with necrotic pulp? participants will undergo regeneration protocol including hyaluronic acid and platelets rich fibrin as scaffolds Researchers will compare \[hyaluronic acid , platelets rich fibrin , and no scaffold \] to see the regenerative potential

Conditions

Regeneration

Outcome Measures

Primary Outcomes (2)

• Clinically by absence of pain and/or swelling

  absence of pain is measured clinically by absence of pain in response to percussion and palation in relation to the related tooth

  1 year

• absence or change of periapical radiolucency.

  absence or change of periapical radiolucency is measured by standardized radiographs (paralleling technique every 3 months and cbct after 1 year)

  1 year

Secondary Outcomes (1)

• measuring different root parameters

  1 year

Study Arms (3)

no scaffold

ACTIVE COMPARATOR

initiate bleeding using hand files size beyond apex with sharp strokes

Procedure: no scaffold

platelets rich fibrin

EXPERIMENTAL

PRF is used as Scaffold by placing the compressed PRF membrane into canal

Procedure: Platelet rich fibrin

hyaluronic acid

EXPERIMENTAL

hyaluronic acid will be delivered by syringe into canal

Procedure: hyaluronic acid

Interventions

Platelet rich fibrin PROCEDURE

PRF membrane is placed as a scaffold inside the canal with no hyaluronic acid

platelets rich fibrin

hyaluronic acid PROCEDURE

hyaluronic acid gel is placed as a scaffold inside the canal with no PRF

hyaluronic acid

no scaffold PROCEDURE

initiate bleeding using hand files size beyond apex with sharp strokes with no PRF or hyaluronic acid placed

no scaffold

Eligibility Criteria

• Age: 9 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with age range from 9-20 years with no sex predilection. Systemically healthy patients.
• Non-vital maxillary anterior presenting with or without signs and/or symptoms of periapical pathology.
• No mobility.
• Pocket depth less than 3 mm.

You may not qualify if:

• Teeth with vertical fracture
• Periodontal involved teeth and non-restorable teeth
• Lack of patient cooperation

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ainshams University

Cairo, 002, Egypt

Location

Related Publications (1)

• Dhillon H, Kaushik M, Sharma R. Regenerative endodontics--Creating new horizons. J Biomed Mater Res B Appl Biomater. 2016 May;104(4):676-85. doi: 10.1002/jbm.b.33587. Epub 2015 Dec 24.

  PMID: 26699211 BACKGROUND

MeSH Terms

Interventions

Hyaluronic Acid

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Mai Abdel Raouf, Teaching assistant

  Ainshams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Teaching assistant, Endodontic department, Faculty of dentistry, Ainshams University

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 18, 2024
• Study Start: December 20, 2022
• Primary Completion: December 20, 2024
• Study Completion: December 20, 2024
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

EG (1)