Maximum Occlusal Bite Force of Necrotic Permanent Teeth Treated by Regenerative Technique: Randomized Clinical Trial

NCT06934317 | Enrolling By Invitation

• 1 other identifier: KingAbdullahUH3
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Further investigation is warranted to ascertain whether the regaining of sensibility and nerve function in regenerated teeth leads to the re-establishment of the proprioceptive protective mechanism inherent in vital teeth. Hence, the primary objective of this prospective randomized clinical trial is to conduct a comparative analysis of the potential effects of pulp revascularization in comparison to conventional endodontic treatments, either RCT or apexification on the Maximum occlusal bite force (MBF) in both immature and mature necrotic permanent teeth. Methods: Upon satisfying the predetermined criteria for inclusion, a total of 184 patients will be recruited for this prospective clinical trial. The study will consist of two groups, specifically Group I: Mature teeth and Group II: Immature teeth, with a sample size of 92 participants in each group. The participants will be assigned randomly to one of the two treatment modalities per group. Group I: will undergo treatment with RCT/revascularization, while Group II will receive MTA plug/revascularization encompassing both mature (n=92) and immature teeth (n=92). MBF will be measured on the selected necrotic teeth prior to clinical intervention, this measurement will be conducted using a portable occlusal force gauge (GM10). Following the completion of therapy, MBF measurements will be repeated at 6 and 12 months to assess long-term outcomes. Subsequently, the collected data will undergo comprehensive analysis.

Conditions

Necrotic Pulp; Regenerative Endodontic Procedures; Bite Force

Keywords

regenerative endodontic; maximum bite force

Outcome Measures

Primary Outcomes (1)

• clinical signs and symptoms

  absence of pain, tenderness, and evidence of radiographic healing

  in 3, 6 and 12 months intervals

Secondary Outcomes (1)

• assesment of pulp vitality

  in 6 and 12 months intervals

Other Outcomes (1)

• maximum bite force

  in 6 and 12 months intervals

Study Arms (3)

Induced bleeding mature and immature group

EXPERIMENTAL

Regeneration procedures will be conducted in two appointments, adhering to the 'Clinical Considerations for a Regenerative Procedure' proposed by the American Association of Endodontists (AAE) in 2021. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph

Diagnostic Test: measurement of maximum bite force using bite fork; Procedure: pulp revascularization by induced bleeding

root canal treated mature group

PLACEBO COMPARATOR

conventional root canal treatment in mature necrotic teeth with periapical lesion

Diagnostic Test: measurement of maximum bite force using bite fork; Procedure: conventional root canal treatment

MtA apexification

PLACEBO COMPARATOR

which includes the immature necrotic permanent teeth, will randomly receive either MTA apexification or revascularization

Diagnostic Test: measurement of maximum bite force using bite fork; Procedure: MTA apexification

Interventions

measurement of maximum bite force using bite fork DIAGNOSTIC_TEST

using bite fork the bite force will be recorded for all teeth preoperative and post operative

Induced bleeding mature and immature group; MtA apexification; root canal treated mature group

conventional root canal treatment PROCEDURE

General principles of conventional endodontic treatment will be applied in all cases, such as the administration of an appropriate local anaesthetic and rubber dam isolation. access and cleaning and shaping using rotary files and obturation. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph

root canal treated mature group

pulp revascularization by induced bleeding PROCEDURE

Regeneration procedures will be conducted in two appointments, adhering to the 'Clinical Considerations for a Regenerative Procedure' proposed by the American Association of Endodontists (AAE) in 2021. All cases will receive a permanent restoration as a final restoration and a post-operative periapical radiograph

Induced bleeding mature and immature group

MTA apexification PROCEDURE

MTA apical plug will be randomly applied to teeth with open apex

MtA apexification

Eligibility Criteria

• Age: 10 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy (ASA Grade 1 \& 2 status). Compliant patient/parent. Mature and immature teeth diagnosed with necrotic pulp. Pulp space is not needed for post and core restoration for cases treated by revascularization.
• Patients are not allergic to the medications necessary to complete the procedure.
• The presence of opposing teeth for the included necrotic teeth. No medication (steroids) at the time of investigation, and the patient should not have taken analgesics 6 hours ago.

You may not qualify if:

• Medically compromised patient. Patient with generalized chronic periodontitis. Patient with TMD. Current orthodontic treatment. Teeth with sensitivity to percussion. Teeth with previous root canal treatment. Periodontal pocket more than 3mm. Teeth with vertical fractures. Teeth with large restorations, either direct or indirect restoration Teeth with large carious lesions. Non-restorable teeth.

Sponsors & Collaborators

• Lama Awawdeh: lead

Study Sites (1)

Postgraduate Dental Clinic Jordan University of Science and Technology

Irbid, POBOX 3030, Jordan

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: December 20, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

JO (1)