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Conventional Coronectomy vs Coronectomy in Combination Vital Pulp Treatment Using Calcium Silicate

NCT05882162 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-06-06

No results posted yet for this study

Summary

The aim of this study was to compare the conventional coronectomy and the combined coronectomy technique with vital pulp treatment. The primary outcome of the study was to evaluate the success rates of two treatment techniques based on clinical and radiologic observations regarding inferior alveolar nerve injury, root exposure and formation of periapical lesion. The secondary outcome was to evaluate the change in periodontal condition of the second molar adjacent to the operation area, dentin bridge formation and root migration.

Between March 2018 and February 2022 eligible patients attended University Hospital for the removal of lower third molar with risk of inferior alveolar nerve (IAN) damage invited to the study. 60 teeth meeting the inclusion criteria in 52 participants were randomized to Test (with BiodentineTM, n=30) and Control (without BiodentineTM, n=30) groups. Neurological injury and post-operative pain were clinically evaluated at 12th months and 1st week, respectively. Root migration, dentin bridge formation and periapical lesion development were evaluated using Cone Beam Computed Tomography (CBCT) at 12th month. The change in the periodontal status of second molar was evaluated by measurement of pocket depth at 1st, 3rd and 12th months and the distance between base of the bone defect and the marginal crest and cemento-enamel junction and at 6th and 12th months month.

Conditions

  • Impacted Third Molar Tooth

Interventions

PROCEDURE

Coronectomy

Removal of crown part of the mandibular third molar

PROCEDURE

Pulp Capping with calcium silicate

Application of a pulp capping material (BiodentineTM, Septodont, St Maur-des-Fosses, France) on pulp tissue to preserve the vitality of the residual pulp and prevent inflammation

Sponsors & Collaborators

  • zeynep cukurova yilmaz

    lead OTHER

Principal Investigators

  • Zeynep Çukurova Yılmaz, DDS,PhD · Private Practice

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-20
Primary Completion
2022-02-20
Completion
2022-04-20

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05882162 on ClinicalTrials.gov