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Completed

NCT Number: NCT06620718

Evaluation of Root Migration Distance After Coronectomy of Impacted Third Molars

The aims of this study were to investigate postoperative pain, edema, and trismus after coronectomy procedure, to assess the risk of endodontic lesion formation at sixth month, and to determine relationship of the root migration distance with age.

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Key information

Conditions

Impacted Tooth With Abnormal Positioning

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatay Mustafa Kemal University

Hatay, Turkey (Türkiye)

About this study

The roots of impacted lower third molars may be associated with the inferior alveolar nerve (IAN). To mitigate this risk and reduce trauma to the patient, a conservative approach involving the removal of the problematic crown portion and leaving the root may be adopted.

This clinical study was conducted between 2021-2022 years and was accordance with the Helsinki Declaration of 1975, as revised 2013. All subjects were informed about the study and clinical procedures and provided written consent The study included 73 patients aged between 18-55 years. These patients were divided into two age groups: The first group, consisting of patients aged 18-30. The second group, consisting of patients aged 31-55.

The coronectomy was surgically performed. Postoperative pain, swelling, and interincisal distance were evaluated based on age. Pain was assessed using a 10 cm Visual Analog Scale (VAS) with patients providing ratings before the operation and on the 3rd and 7th postoperative days. The progresion of endodontic lesion was evaluated in 6 months after coronectomy.

The distance of root migration achieved at 6 months after coronectomy was measured by independent examiner. Calibrated panoramic radiographs were used to determine the level of migration.

The statistical analysis of the data obtained in our study was performed using SPSS software The needed statistical analyses were used for comparison of the data. The Levene test was used for comparison of the root migration distances in the age groups. The significance level was set at 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study focused on applying coronectomy, a more conservative approach, instead of extraction for mandibular third molars associated with the inferior alveolar nerve that were indicated for prosthetic, orthodontic, prophylactic purposes, or those causing pericoronitis
  • Systemically health,
  • To maintain ideal oral hygiene,
  • Absence of caries, pulpal and endodontic lesions in the impacted third molar indicated for extraction
  • No known allergies to any antibiotics, or no use or history of bisphosphonate medication
  • No use of tobacco or any illicit drugs by the patient.
  • Not being pregnant

Exclusion criteria

  • Other conditions unlike abovementioned items.

Treatment and study plan

Coronectomy

Procedure

The inferior alveolar nerve and buccal nerve were blocked with maxicaine anaesthetic solution (articaine hydrochloride 40 mg, epinephrine hydrochloride 0.006 mg). Incisions were applied uniformly across all patients, and a triangular flap technique was employed. After elevating the flap and exposing the bone, the bone overlying the crown of the tooth was removed using a bone round bur to fully visualize the tooth's crown. Once the crown was fully exposed, the crown preparation was initiated at the enamel-dentin junction using a fissure bur. The crown preparation was completed without leaving any sharp edges, and the crown was extracted. Then, the exposed pulp was washed with sterile serum without any further intervention. The surgical area was sutured using 5/0 silk. Analgesic (25 mg of dexketoprofen trometamol twice a day) and antibiotic (125 mg clavulanic acid, 875 mg amoxicilin twice a day) drugs were described.

Primary outcomes

  1. the mesaurement of root migration distance

    Time frame: six months after coronectomy procedure

    the distance from the enamel-cement line of the adjacent tooth to the remaining root or roots after coronectomy.

Secondary outcomes

  1. the percentage of edema

    Time frame: postoperatively 3rd and 7th day after coronectomy

    percentage of edema was measured extraorally

  2. the measurement of the distance of interincisal opening

    Time frame: postoperatively 3rd and 7th day after coronectomy

    maximum interincisal distance was measured using a calliper during the maximum opening of the mouth

  3. the pain assessment

    Time frame: postoperatively 3rd and 7th day after coronectomy

    A 10 cm or 100 mm-Visual Analogue Scale was used for assessment. The findings suggested that 100-mm VAS ratings of 0 to 4 mm can be considered no pain; 5 to 44 mm, mild pain; 45 to 74 mm, moderate pain; and 75 to 100 mm, severe pain.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study title

Evaluation of Pain and Root Migration Distance After Coronectomy Procedure of Impacted Third Molars Based on Age

Acronym: NonRCT

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 1, 2024
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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