Success Rate of Single Versus Two Visit Regenerative Treatment Protocol in Non Vital Mature Anterior Teeth

NCT03717337 | Unknown

• 1 other identifier: Faculty of dentistry 2018
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates success rate of non vital mature anterior teeth with periapical lesion treated by regenerative endodontic protocol in single visit versus two visit technique. Patients are randomized into two groups where treatment will be done either in one visit including access, disinfection, placing platelet rich plasma as scaffold and restoration or two visit protocol involving access, disinfection and placing calcium hydroxide as intracanal medicament in first visit followed by a second visit after 3 weeks involving reopening of the tooth, removing intracanal medicament and placing platelet rich plasma as scaffold then restoration. Success rate is defined as absence of subjective signs and symptoms along with healing of periapical lesion

Conditions

Pulp Necrosis; Periapical Lesion; Anterior Teeth

Keywords

Regeneration, mature teeth, regenerative procedures

Outcome Measures

Primary Outcomes (3)

• Change in Post operative pain: NRS

  absence of pain reported by the patient by numerical rate scale, the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable")

  3, 6, 9 and 12 months

• Change in swelling and/or sinus

  The presence of swelling or sinus will be reported by a binary question yes/no

  3,6,9,12 months

• Periapical healing

  The existing periapical lesion will be measured by mm by CBCT before intiation of treatment and after one year

  12 months

Secondary Outcomes (3)

• Antimicrobial effect

  before and after complete disinfection either in the same visit or after 3 weeks from the second visit

• Sensitivity

  3, 6, 9 and 12 months

• Discoloration

  3, 6, 9 and 12 months

Study Arms (2)

Single visit pulp regeneration

EXPERIMENTAL

Regenerative endodontic procedure not involving placement of intracanal medicament will be done in single visit

Procedure: Single visit pulp regeneration

Two visit pulp regeneration

ACTIVE COMPARATOR

Regenerative endodontic procedure involving placing intracanal medicament will be done in two visit

Procedure: Two visit pulp regeneration

Interventions

Single visit pulp regeneration PROCEDURE

Access cavity, disinfection, preparing and injecting platelet rich plasma, and restoring the tooth all done in one visit.

Single visit pulp regeneration

Two visit pulp regeneration PROCEDURE

first visit : access, disinfection and placing calcium hydroxide as intracanal medicament second visit: re opening of tooth, preparing and injecting platelet rich plasma and restoring the tooth.

Two visit pulp regeneration

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Single canal anterior tooth
• Mature root
• Non vital with radiographic evidence of periapical lesion
• Periapical lesion of average size 2-5mm
• Positive patient compliance for participation in the study.
• Patients with good oral hygiene
• Normal periodontal probing depth ≤ 3 mm

You may not qualify if:

• Compromised remaining tooth structure that need post and core build up
• Non restorable teeth
• Vital teeth
• Radiographic evidence of external or internal root resorption.
• Roots showing fracture or ankylosis
• Medically compromised patients
• Pregnant women
• Greater than grade I mobility or periodontal probing depth greater than 3mm
• Immature tooth
• Patients with pain, swelling or fistula tracts

Sponsors & Collaborators

• Cairo University: lead

Related Publications (1)

• Lasheen LR, Gawdat SI, Lutfy RA. Success Rate of Single Versus Two-Visit Regenerative Treatment Protocol in Non-Vital Mature Anterior Teeth (A Preliminary Randomised Clinical Trial). Aust Endod J. 2025 Aug;51(2):308-316. doi: 10.1111/aej.12943. Epub 2025 Apr 11.

  PMID: 40219648 DERIVED

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: OUTCOMES ASSESSOR
• Masking Details: single
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of endodontics

Model Details: The design of this randomized clinical trial is a parallel group two arms trial with 1:1 allocation ratio

Study Record Dates

• First Submitted: October 14, 2018
• First Posted: October 24, 2018
• Study Start: January 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 24, 2018

Record last verified: 2018-10