NCT06620718

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
73

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 1, 2024

Completed
Last Updated

October 1, 2024

Status Verified

September 1, 2024

Enrollment Period

1.7 years

First QC Date

September 24, 2024

Last Update Submit

September 26, 2024

Conditions

Keywords

coronectomy of impacted third molar tooth

Outcome Measures

Primary Outcomes (1)

  • the mesaurement of root migration distance

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

    six months after coronectomy procedure

Secondary Outcomes (3)

  • the percentage of edema

    postoperatively 3rd and 7th day after coronectomy

  • the measurement of the distance of interincisal opening

    postoperatively 3rd and 7th day after coronectomy

  • the pain assessment

    postoperatively 3rd and 7th day after coronectomy

Study Arms (1)

Evaluation of root migration at sixth month after coronectomy

OTHER

Seventy three patients were divided into two age groups: The first group, consisting of patients aged 18-30, included 17 males and 23 females. The second group, consisting of patients aged 31-55, included 17 males and 16 females

Procedure: coronectomy

Interventions

coronectomyPROCEDURE

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.

Evaluation of root migration at sixth month after coronectomy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Other conditions unlike abovementioned items.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, Turkey (Türkiye)

Location

Related Publications (6)

  • Hashemipour MA, Tahmasbi-Arashlow M, Fahimi-Hanzaei F. Incidence of impacted mandibular and maxillary third molars: a radiographic study in a Southeast Iran population. Med Oral Patol Oral Cir Bucal. 2013 Jan 1;18(1):e140-5. doi: 10.4317/medoral.18028.

    PMID: 23229243BACKGROUND
  • Satilmis T, Garip H, Arpaci E, Sener C, Goker K. Assessment of combined local anesthesia and ketamine for pain, swelling, and trismus after surgical extraction of third molars. J Oral Maxillofac Surg. 2009 Jun;67(6):1206-10. doi: 10.1016/j.joms.2008.12.034.

    PMID: 19446205BACKGROUND
  • Agbaje JO, Heijsters G, Salem AS, Van Slycke S, Schepers S, Politis C, Vrielinck L. Coronectomy of Deeply Impacted Lower Third Molar: Incidence of Outcomes and Complications after One Year Follow-Up. J Oral Maxillofac Res. 2015 Jun 30;6(2):e1. doi: 10.5037/jomr.2015.6201. eCollection 2015 Apr-Jun.

    PMID: 26229580BACKGROUND
  • Ghaeminia H, Meijer GJ, Soehardi A, Borstlap WA, Mulder J, Berge SJ. Position of the impacted third molar in relation to the mandibular canal. Diagnostic accuracy of cone beam computed tomography compared with panoramic radiography. Int J Oral Maxillofac Surg. 2009 Sep;38(9):964-71. doi: 10.1016/j.ijom.2009.06.007. Epub 2009 Jul 28.

    PMID: 19640685BACKGROUND
  • Pedersen MH, Bak J, Matzen LH, Hartlev J, Bindslev J, Schou S, Norholt SE. Coronectomy of mandibular third molars: a clinical and radiological study of 231 cases with a mean follow-up period of 5.7years. Int J Oral Maxillofac Surg. 2018 Dec;47(12):1596-1603. doi: 10.1016/j.ijom.2018.06.006. Epub 2018 Jul 14.

    PMID: 30017572BACKGROUND
  • Monaco G, de Santis G, Gatto MR, Corinaldesi G, Marchetti C. Coronectomy: a surgical option for impacted third molars in close proximity to the inferior alveolar nerve. J Am Dent Assoc. 2012 Apr;143(4):363-9. doi: 10.14219/jada.archive.2012.0178.

    PMID: 22467696BACKGROUND

Study Officials

  • Osman F ARPAĞ, Mr

    Mustafa Kemal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
measurement the distance of root migration at sixth month
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A total of 78 patients were initially included in the study, but five patients were excluded from the study due to their failure to attend regular follow-up visit, resulting in a final analysis of 73 patients (Figure 1). These patients were divided into two age groups: The first group, consisting of patients aged 18-30, included 17 males and 23 females. The second group, consisting of patients aged 31-55, included 17 males and 16 females.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, PhD

Study Record Dates

First Submitted

September 24, 2024

First Posted

October 1, 2024

Study Start

January 1, 2021

Primary Completion

September 15, 2022

Study Completion

December 30, 2022

Last Updated

October 1, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations