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

NCT05882162 | Completed

• 1 other identifier: 66291034-604.01.01-E.46464-17
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

coronectomy; vital pulp therapy; impacted third mandibular molar

Outcome Measures

Primary Outcomes (3)

• Presence of inferior alveolar nerve injury (yes/no)

  Hypoesthesia/hyperesthesia/dysesthesia in the lower lip or mental region of the operated side were the clinical findings for nerve injury

  12 months

• Root exposure (yes/no)

  Total removal of the residual roots was required in case of eruption of the residual roots detected clinically

  12 months

• Periapical lesion (yes/no)

  Detection of periapical lesion due to necrosis of the residual root pulp radiographically (panoramic radiographs and CBCT) indicated failure of the treatment

  12 Months

Secondary Outcomes (4)

• Dentin bridge formation (yes/no)

  12 months

• Pain (1-10)

  1 week

• Root migration (yes/no)

  12 months

• Maintenance of periodontal status of the adjacent tooth (yes/no)

  3,6 and 12 months

Study Arms (2)

Control Group

ACTIVE COMPARATOR

A scalpel number 15 was used to raise a triangular or envelope-shaped full-thickness mucoperiosteal flap. The bone in the buccal cavity of the third molar was removed with steel rounds and fissure burs to reach the cementum-enamel boundary. 3/4 of the tooth was cut bucco-lingually from 1-2 mm apical to the enamel cement border with the help of a high-speed surgical handpiece with a fissure steel bur. The root surface was positioned 2-3 mm apically from the surrounding alveolar bone level with the help of a steel round bur. The remaining enamel tissue and pulpal tissue in the coronal part were completely removed. Calcium silicate material was not used for pulp capping of the root pulp. During the procedure, the mandibular second molar's surface was curetted, and the surgical area was rinsed with saline solution to remove any potential surgical debris. The required number of simple sutures were used to close the surgical field without tension.

Procedure: Coronectomy

Test Group

EXPERIMENTAL

A scalpel number 15 was used to raise a triangular or envelope-shaped full-thickness mucoperiosteal flap. The bone in the buccal cavity of the third molar was removed with steel rounds and fissure burs to reach the cementum-enamel boundary. 3/4 of the tooth was cut bucco-lingually from 1-2 mm apical to the enamel cement border with the help of a high-speed surgical handpiece with a fissure steel bur. The root surface was positioned 2-3 mm apically from the surrounding alveolar bone level with the help of a steel round bur. The remaining enamel tissue and pulpal tissue in the coronal part were completely removed. Calcium silicate material was used for pulp capping of the root pulp. During the procedure, the mandibular second molar's surface was curetted, and the surgical area was rinsed with saline solution to remove any potential surgical debris. The required number of simple sutures were used to close the surgical field without tension.

Procedure: Coronectomy; Procedure: Pulp Capping with calcium silicate

Interventions

Coronectomy PROCEDURE

Removal of crown part of the mandibular third molar

Control Group; Test Group

Pulp Capping with calcium silicate PROCEDURE

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

Test Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Patients without any systemic disorders
• Close relationship of the lower third molar and inferior alveolar nerve (IAN) on orthopantomography (OPTG) and Cone Beam Computed Tomography (CBCT)
• Pericoronitis around the third molar
• Caries presence or risk for caries development on the distal surface of adjacent second molar
• Follicle enlargement of less than 3 mm around the crown of the mandibular third molar on OPTG
• Teeth with complete apex development

You may not qualify if:

• Presence of active infection (irreversible pulpitis) and/or pathology in the tooth
• In the presence of mobility in tooth
• Teeth with a horizontal position that are closely related to the IAN at the coronal portion
• Teeth undergoing resorption
• Smokers
• Patients who declined to take part in the study.

Sponsors & Collaborators

• zeynep cukurova yilmaz: lead

Study Sites (1)

İstanbul Medipol University

Istanbul, Esenler, 34230, Turkey (Türkiye)

Location

Related Publications (20)

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• da Fonseca TS, Silva GF, Guerreiro-Tanomaru JM, Delfino MM, Sasso-Cerri E, Tanomaru-Filho M, Cerri PS. Biodentine and MTA modulate immunoinflammatory response favoring bone formation in sealing of furcation perforations in rat molars. Clin Oral Investig. 2019 Mar;23(3):1237-1252. doi: 10.1007/s00784-018-2550-7. Epub 2018 Jul 7.

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MeSH Terms

Interventions

Dental Pulp Capping; calcium silicate

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Zeynep Çukurova Yılmaz, DDS,PhD

  Private Practice

  STUDY DIRECTOR

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: SPONSOR INVESTIGATOR
• PI Title: Asst. Prof. Zeynep Çukurova Yılmaz

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: May 31, 2023
• Study Start: March 20, 2018
• Primary Completion: February 20, 2022
• Study Completion: April 20, 2022
• Last Updated: June 6, 2023

Record last verified: 2023-06

Locations

TU (1)