Coronectomy of the lower wisdom tooth in older adults
| ISRCTN | ISRCTN15812606 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15812606 |
| Secondary identifying numbers | W19_015# 19.033 |
- Submission date
- 12/06/2024
- Registration date
- 14/06/2024
- Last edited
- 14/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Coronectomy is an alternative to complete surgical removal of a mandibular third molar (wisdom tooth) that is near the inferior alveolar nerve. It involves removing the crown of the tooth while leaving the roots intact. This study investigates the effect of coronectomy on postoperative quality of life in older adults.
Who can participate?
Patients aged over 60 years who require coronectomy of a mandibular third molar
What does the study involve?
Patients undergo coronectomy on a mandibular third molar. During the first week after surgery, patients fill in a questionnaire and they are followed up at 1 week, 3 months, 6 months, and 1 year (patients are followed up annually up to 5 years later).
What are the possible benefits and risks of participating?
There are no risks of participating. The surgery has to be performed. The benefits are that we gain insight into the impact on the Oral Health-Related Quality of Life after a coronectomy of a mandibular third molar in the older patient population.
Where is the study run from?
Amstelland Hospital (The Netherlands)
When is the study starting, and how long is it expected to run?
July 2018 to December 2021
Who is funding the study?
Amstelland Hospital (The Netherlands)
Who is the main contact?
Dr J.A.H. Lindeboom, j.a.lindeboom@amsterdamumc.nl
Contact information
Public, Scientific, Principal Investigator
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
 ORCID ID |
0000-0001-8249-3774 |
|---|---|
| Phone | +31 (0)628786565 |
| j.a.lindeboom@amsterdamumc.nl |
Scientific
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
| Phone | +31 (0)205664098 |
|---|---|
| j.delange@amsterdamumc.nl |
Public
Meibergdreef 9
Amsterdam
1105AZ
Netherlands
| Phone | +31 (0)205664098 |
|---|---|
| j.g.tuk@amsterdamumc.nl |
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet: j.a.lindeboom@amsterdamumc.nl |
| Scientific title | Mandibular third molar coronectomy in older adults and effects on oral health-related quality of life |
| Study hypothesis | This study aimed to assess the effect of coronectomy on the postoperative quality of life during the first postoperative week in older adults using the Oral Heal Impact Profile-14 (OHIP-14) questionnaire. Factors potentially influencing the postoperative OHIP-14 score, such as smoking, impaction pattern of the mandibular third molar, inclination of the mandibular third molar, and state of eruption, were also evaluated. Patients were monitored up to a minimum of 1 year after the surgery. |
| Ethics approval(s) |
Approved 23/01/2019, Academic Medical Center Medical Ethical Committee (Meibergdreef 9, Amsterdam, 1105AZ, Netherlands; +31 (0)205667389; metc@amsterdamumc.nl), ref: W19_015# 19.033 |
| Condition | Impacted mandibular third molar |
| Intervention | Patients undergo coronectomy on a mandibular third molar. During the first week after surgery, patients fill in an Oral Health Impact Profile-14 (OHIP-14) questionnaire. This study's follow-up was at 1 week, 3 months, 6 months, and 1 year (patients are followed up annually up to 5 years postoperative). |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Oral health related quality of life measured with the OHIP-14 questionnaire each day of the first postoperative week |
| Secondary outcome measures | 1. Postoperative pain measured using the visual analog score (VAS) during the 1st postoperative week 2. Swelling (self-reported yes/no) during the 1st postoperative week 3. Trismus (self-reported yes/no) during the 1st postoperative week 4. Postoperative bleeding (self-reported yes/no), during the 1st postoperative week 5. Infection (yes or no infection) assessed by the clinician at 1 week 6. Potential neurosensory deficits assessed by the clinician using tactile, two-point discrimination, thermal change detection and heat pain thresholds at 1 week, 3 months, 6 months, and 1 year 7. Postoperative self-care behaviors: use of analgesics and cooling the cheek with ice on the first postoperative day |
| Overall study start date | 01/07/2018 |
| Overall study end date | 31/12/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 60 Years |
| Upper age limit | 100 Years |
| Sex | Both |
| Target number of participants | 30 |
| Total final enrolment | 30 |
| Participant inclusion criteria | 1. An indication for coronectomy on a mandibular third molar 2. A minimum age of 60 years at the time of the surgery 3. Fluency in Dutch to complete the Dutch version of the OHIP-14 questionnaire |
| Participant exclusion criteria | 1. <60 years old 2. Did not have an indication for coronectomy of a mandibular third molar |
| Recruitment start date | 01/02/2019 |
| Recruitment end date | 31/12/2020 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amstelveen
1181AM
Netherlands
Sponsor information
Hospital/treatment centre
Department of Oral and Maxillofacial Surgery
Laan van de Helende Meesters 8
Amstelveen
1188 AM
Netherlands
| Phone | +31 (0)207557027 |
|---|---|
| kaakpo@zha.nl | |
| Website | https://www.ziekenhuisamstelland.nl/nl/ |
"ROR" |
https://ror.org/05e73v668 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
14/06/2024: Study's existence confirmed by the Academic Medical Center Medical Ethical Committee.
