Impacted Tooth With Abnormal PositioningNonRCTNCT06620718
Evaluation of Root Migration Distance After Coronectomy of Impacted Third Molars
A study testing coronectomy in people with Impacted Tooth With Abnormal Positioning, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Impacted Tooth With Abnormal Positioning
- What is being tested?
- coronectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 30 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Other conditions unlike abovementioned items.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Pain and Root Migration Distance After Coronectomy Procedure of Impacted Third Molars Based on Age
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.
Read the detailed description
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.
- Conditions
- Impacted Tooth With Abnormal Positioning
- Being tested
- coronectomy
- Keywords
- coronectomy of impacted third molar tooth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: coronectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: six months after coronectomy procedure
Secondary outcomes (3)
the percentage of edema
percentage of edema was measured extraorally
Measured: postoperatively 3rd and 7th day after coronectomy
the measurement of the distance of interincisal opening
maximum interincisal distance was measured using a calliper during the maximum opening of the mouth
Measured: postoperatively 3rd and 7th day after coronectomy
the pain assessment
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.
Measured: postoperatively 3rd and 7th day after coronectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start1 Jan 2021
- Primary completion15 Sep 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Impacted Tooth With Abnormal PositioningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osman Fatih Arpag, Mustafa Kemal University
- Investigators
- Osman F ARPAĞ, Mr, Principal investigator, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06620718
- Sponsor's protocol ID
- 2022/49
- Acronym
- NonRCT
- Status last verified
- Sep 2024
- First submitted
- 24 Sep 2024
- Last updated
- 1 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23229243Satilmis 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.
PubMed 19446205Agbaje 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.
PubMed 26229580Ghaeminia 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.
PubMed 19640685Pedersen 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.
PubMed 30017572Monaco 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.
PubMed 22467696
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pain and Root Migration Distance After Coronectomy Procedure of Impacted Third Molars Based on Age
- ClinicalTrials.gov ID
- NCT06620718
- Acronym / sponsor ID
- NonRCT / 2022/49
- Conditions
- Impacted Tooth With Abnormal Positioning
- Keywords
- coronectomy of impacted third molar tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 1 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Evaluation of root migration at sixth month after coronectomy | Other | Procedure: coronectomySeventy 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- Other conditions unlike abovementioned items.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronectomyThe 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. | Procedure or surgery | Evaluation of root migration at sixth month after coronectomy |
Primary outcome
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.
3 secondary outcomes
the percentage of edema
Time frame: postoperatively 3rd and 7th day after coronectomy
the measurement of the distance of interincisal opening
Time frame: postoperatively 3rd and 7th day after coronectomy
the pain assessment
Time frame: postoperatively 3rd and 7th day after coronectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2024.
- Background: PubMed 23229243Hashemipour 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.
- Background: PubMed 19446205Satilmis 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.
- Background: PubMed 26229580Agbaje 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.
- Background: PubMed 19640685Ghaeminia 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.
- Background: PubMed 30017572Pedersen 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.
- Background: PubMed 22467696Monaco 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osman F ARPAĞ, Mr principal investigator
Mustafa Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coronectomy in people with Impacted Tooth With Abnormal Positioning, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mesaurement of root migration distance (time frame: six months after coronectomy procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06620718, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2024.