Outcome of NSRCT Versus VPT in Management of Teeth with Symptomatic Irreversible Pulpitis Associated with Apical Periodontitis

NCT06226870 | Active Not Recruiting

• 1 other identifier: NSRCT versus VPT
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Pulpitis is the pulpal inflammation in response to irritants which are either microbial, chemical, or physical (mechanical and thermal) in origin. Clinically, pulpitis is termed as reversible or irreversible, whereas histologically, it is described as acute, chronic or hyperplastic . Pulpitis is considered reversible when the pulp can heal following conservative management . For such cases, a coronal pulpotomy is considered as a definitive treatment option having 78% to 90% of success rate . In irreversible pulpitis (IP), the pulp is not capable of healing, thus it is treated traditionally complete pulpectomy.

Conditions

Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (2)

• Postoperative pain

  Preoperative and postoperative pain will be recorded on a point numeric rating scale by another operator. The numerical scale of pain is most commonly from 0 to 10, with 0 being "no pain" the lowest value and 10 being "the worst pain imaginable refer to the highest value, the lowest value means better outcome results.

  at 24, 48 and 72-hours

• Radiographic evaluation

  CBCT will be taken postoperatively to assess the periapical healing based on periapical index ( PAI) score. PAI score is ordinal scale of 5 scores ranging from 1 (healthy) lowest value to 5 (severe periodontitis with exacerbating features) highest value . The lowest value means better outcome.

  at baseline ,6 and 12-months

Study Arms (3)

NSRCT Group

EXPERIMENTAL

Non-surgical root canal therapy

Procedure: root canal tretment

VPT Group

EXPERIMENTAL

vital pulp therapy

Procedure: biodentin VPT

VPT+PRF Group

EXPERIMENTAL

vital pulp therapy with PRF

Procedure: PRF

Interventions

root canal tretment PROCEDURE

traditional therapy

Also known as: RCT

NSRCT Group

biodentin VPT PROCEDURE

Alternative therapy

Also known as: VPT

VPT Group

PRF PROCEDURE

Alternative therapy

Also known as: PRF plus VPT

VPT+PRF Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy patients (Category: American society of anesthesiologists class I) of either gender aged from 18-40 years.
• Permanent mature mandibular first molars with a definitive clinical diagnosis of SIP (positive response to pulp sensibility test) with SAP (PAI score ≤ 3)

You may not qualify if:

• Patients with systemic diseases such as (diabetes, hypertension, etc.…).
• Immunocompromised patients.
• Pregnant women and smokers.
• Patients with a history of antibiotic or analgesics intake within the few days before the intervention and cases with previously initiated endodontic treatment.
• Intraoperatively, where the haemostasis (application of 2.5% sodium hypochlorite pressure pack) could not be achieved within 10 minutes.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Faculty of dentistry

Minya, Egypt

Location

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Abeer H Mahran, professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Computer will be used to generate a sequence of random numbers for the allocation of participants into the groups. Once the computer-generated randomization number will be obtained, it will be sealed in an opaque envelope by one of the investigators. After the clinical and radiographic findings, the envelope will be opened by a clinical assistant and treatment will be allocated to the patient based on the sequence generated. The patients will be blinded about the procedure, and a single operator will perform all the endodontic procedures after the informed written consent.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of Endodontics, Aswan University

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: January 26, 2024
• Study Start: May 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 20, 2024

Record last verified: 2024-03

Locations

EG (1)