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

June 4, 2023 updated by: zeynep cukurova yilmaz

Conventional Coronectomy vs Coronectomy in Combination Vital Pulp Treatment Using Calcium Silicate ?: A Randomized Controlled Trial up to 1 Year

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The surgical removal of mandibular third molar teeth is one of the most frequently performed oral surgical procedures. One of the complications might occur during surgical removal of these teeth is injury to inferior alveolar nerve (IAN) which may lead to altered or loss of sensation to lower lip, chin, teeth and gingiva on the operated side. The risk for IAN injury may not be avoidable, even though the surgery was performed by an experienced surgeon and the positional relationship between the mandibular third molar and IAN was assessed accurately prior to surgery.

Pericoronitis, dental caries and periodontal disease are the most common pathologies associated with mandibular third molar teeth. Theoretically, removal of crown part of the teeth with a vital pulp and leaving the roots behind might be adequate to relive clinical symptoms arise from these pathologies. This technique was first described by Ecuyer and Debien in 1984 as coronectomy to prevent injury in case of close relationship of mandibular third molar with inferior IAN.

As shown previously in randomized clinical trials, fewer complications in terms of post-operative pain, IAN deficiency and dry socket were observed after coronectomy. Systematic reviews have confirmed that incidence of IAN injury was lower with coronectomy when compared to total removal in case of the lower third molar radiographically closely related with the IAN. Nerve injury was reported to occur in up to 20% of cases temporarily and 1-4% of cases permanently after total extraction, whereas 0-5.5% of cases temporarily after coronectomy.

Radiographic assessment using panaromic radiographs is the first step for coronectomy procedure. Presence of the interruption of the white line of the mandibular canal wall, darkening around the root(s), diverging of the mandibular canal, narrowing of the mandibular canal, narrowing of the root(s) and deflection of the root(s) are the indicators of increased risk for IAN injury. In recent years, cone beam computer tomography (CBCT) scanning is widely used method for further investigation to demonstrate the three-dimensional relationship between the tooth and IAN. Additionally, eligibility of the third molar for coronectomy should also be evaluated to be free of caries, pulpal inflammation and abnormal surrounding tissue. Coronectomy is contraindicated for non-compromised patients with good healing potential due to medical conditions such as diabetics, long-term steroid use, chemotherapy or radiotherapy.

One of the possible complications after coronectomy is migration and eruption of the roots left in the bone. Bone formation over the retained roots is expected to avoid eruption of these roots in the oral cavity. In case of eruption, remaining roots should be extracted. Another possible complication is periapical lesion development due to necrosis of the pulp. With conventional coronectomy procedure, no pulp treatment of the remaining roots is performed. Previous in vivo studies demonstrated that pulp retained vital after coronectomy. However, presence of pain and infection after coronectomy was reported in randomized clinical trials. Vital pulp treatment of the remaining roots with a bioactive material may have the potential to enhance both dentin and bone formation leading to reduced complications related with periapical inflammation and tooth migration.

In the literature, there is no study concerned with the clinical success of coronecyomy in combination with vital pulp treatment, except a case report. Therefore, the aim of this randomized clinical trial was to compare clinical success of conventional coronectomy and coronectomy in combination with vital pulp treatment based on clinical and radiologic evalutions. The null hypothesis tested in this study was that application of calcium silicate (Biodentine, Septodont, St Maur-des-Fosses, France) after coronectomy had no benefits to reduce above mentioned post-operative complications.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Esenler
      • İstanbul, Esenler, Turkey, 34230
        • Istanbul Medipol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • - 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

Exclusion Criteria:

  • -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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
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
Removal of crown part of the mandibular third molar
Experimental: Test Group
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of inferior alveolar nerve injury (yes/no)
Time Frame: 12 months
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)
Time Frame: 12 months
Total removal of the residual roots was required in case of eruption of the residual roots detected clinically
12 months
Periapical lesion (yes/no)
Time Frame: 12 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dentin bridge formation (yes/no)
Time Frame: 12 months
Presence of dentin bridge formation at the coronal part of the root pulp indicated preservation of the vitality of the root pulp
12 months
Pain (1-10)
Time Frame: 1 week
Assessment of postoperative pain using a visual analog scale (VAS) printed on paper ranging from no pain to unbearable pain (1-10).
1 week
Root migration (yes/no)
Time Frame: 12 months
The movement of the residual roots after coronectomy evaluated by comparing the distance between the roots with and the inferior alveolar nerve radiographically. At baseline the roots of all of the third molars were close proximity with the inferior alveolar nerve.
12 months
Maintenance of periodontal status of the adjacent tooth (yes/no)
Time Frame: 3,6 and 12 months
Periodontal health of the second molar adjacent to operation site was evaluated according to measurement (milimeter) of probing pocket depth; the distance between base of the bone defect and the marginal crest and the distance between base of the bone defect and cemento-enamel junction. The measurements taken in the designated follow-ups were compared to baseline measurements to assess the change in the periodontal status.
3,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

zeynep cukurova yilmaz

Investigators

  • Study Director: Zeynep Çukurova Yılmaz, DDS,PhD, Private Practice

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2018

Primary Completion (Actual)

February 20, 2022

Study Completion (Actual)

April 20, 2022

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 21, 2023

First Posted (Actual)

May 31, 2023

Study Record Updates

Last Update Posted (Actual)

June 6, 2023

Last Update Submitted That Met QC Criteria

June 4, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66291034-604.01.01-E.46464-17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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