Assessment of Regenerative Potential of Mature Permanent Teeth With Necrotic Pulps Using Two Revascularization Protocols. (In Vivo Study)

NCT04158232 | Unknown

• 1 other identifier: 306
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Regenerative endodontic procedures have been used to successfully treat human mature permanent teeth with necrotic pulps and apical periodontitis. Many researchers have begun to apply regenerative endodontic procedures to mature teeth in adult patients. Several clinical case reports have shown complete resolution of signs and symptoms of pulp necrosis in mature teeth, even those with large periapical lesions, as well as signs of pulp canal obliteration. thevaim of this study is To assess the regenerative potential of mature permanent teeth with necrotic pulps with platelet-rich fibrin (PRF) and blood clot using radiographic and clinical methods.

Conditions

Apical Periodontitis

Outcome Measures

Primary Outcomes (2)

• clinical success

  pulp vitality testing using electric pulp tester which detect response of pulp to electric current

  9 months

• radiographic success

  healing of apical periodontitis by detecting change in apical radiolucency and absences of apical bone resorption

  9 months

Study Arms (2)

Blood clotting protocol for pulp regeneration

ACTIVE COMPARATOR

pulp regeneration for mature teeth using blood clotting protocol

Other: Method

platelet rich fibrin for pulp regeneration

EXPERIMENTAL

pulp regeneration for mature teeth using platelet rich fibrin (PRF)

Other: Method

Interventions

Method OTHER

treatment of mature teeth with apical periodontitis

Blood clotting protocol for pulp regeneration; platelet rich fibrin for pulp regeneration

Eligibility Criteria

• Age: 11 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with mature teeth.
• Patients with periapical periodontitis.
• Maxillary anterior teeth only will be involved.
• Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
• Patients who will agree to the consent and will commit to follow up period.

You may not qualify if:

• Patients with immature roots.
• Patients with any systemic disease that may affect normal healing.
• Patients with swelling.
• Pregnant females.
• Patients who could/would not participate in a 1 year follow up.
• Patients with fistula.
• Patients with old age.
• Teeth with periodontal involvement.
• Teeth with vertical root fractures.
• Unrestorable teeth.

Sponsors & Collaborators

• Minia University: lead

Related Publications (1)

• Youssef A, Ali M, ElBolok A, Hassan R. Regenerative endodontic procedures for the treatment of necrotic mature teeth: A preliminary randomized clinical trial. Int Endod J. 2022 Apr;55(4):334-346. doi: 10.1111/iej.13681. Epub 2022 Jan 31.

  PMID: 35030270 DERIVED

MeSH Terms

Conditions

Periapical Periodontitis

Interventions

Methods

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 8, 2019
• Study Start: November 2, 2019
• Primary Completion: September 2, 2020
• Study Completion: November 2, 2020
• Last Updated: November 8, 2019

Record last verified: 2019-11