Impacted Third Molar ToothNCT06262841
Post-Surgical Morbidity and Bone Healing of Impacted Lower Third Molars: Piezosurgery vs. Conventional Instruments
A study testing Piezosurgery and Conventional burs in people with Impacted Third Molar Tooth, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Piezosurgery and Conventional burs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 1 Apr 2023
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA I-II
- Aged 18-35
- Symmetrical Class 2 Position B according to Winter and Pell-gregory classification
- Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index
Who cannot join
- Individuals who had systemic disease affecting bone or soft tissue metabolism
- Smokers (more than 10 cigarettes a day)
- Alcohol dependent
- Systemic disease affecting bone or soft tissue metabolism
- Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Çankaya, 06510
About this study
Official title: Comparative Evaluation of Morbidity and Alveolar Bone Healing After Surgical Extraction of Impacted Lower Third Molar Teeth Using Piezosurgery and Conventional Instruments: A Split-Mouth Clinical Study
The aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.
Read the detailed description
The aim of our study is to comparatively evaluate the duration of the operation and the pain, trismus, edema and healing of the alveolar bone that occur after tooth extraction in surgical extractions of impacted lower third molar teeth using piezosurgery and traditional rotary instruments.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Piezosurgery, Conventional burs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PiezosurgeryDevice
Piezosurgery used as an osteotomy device
Conventional bursDevice
Conventional burs used as an osteotomy device
| Study group | Role | What they receive |
|---|---|---|
| Piezosurgery group | Experimental | In the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar.
Intervention: Device: Piezosurgery Receives: Device: Piezosurgery |
| Conventional group | Active comparator | In the control group, conventional burs were used to remove the bone surrounding the impacted third molar.
Intervention: Device: Conventional burs Receives: Device: Conventional burs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oral Health-related Quality of Life
Evaluated by Oral Health Impact Profile-14 questionnaire (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better Oral Health Related Quality of Life.
Measured: Time Frame: 14 days
Secondary outcomes (4)
Change in pain
Postoperative pain was assessed using a Visual Analogue Scale (VAS) ranging from the absence of pain (score 0) to the most severe pain imaginable
Measured: 7 days
Change in Mouth opening
The distance between the mesio-incisal corners of the upper and lower central incisors was measured with the help of a ruler when the mouth opening was at its maximum.
Measured: 7 days
Operation time
The total time from the first incision of the operation site to the last suture was measured with the help of a digital stopwatch as the operation time.
Measured: Intraoperative
Change in facial swelling
With the technique described by Neupert ; Angle of mandible-tragus Angle of mandible-lateral canthus of eye Mandible corner-nose wing Angle of mandible oral-commissures Measurements were made with a tape measure from 5 points, with the mandible corner-pogonion.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2024
- Study start1 Nov 2022
- Primary completion1 Apr 2023
- Study completion1 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Kaan Erdem, Ankara University
- Investigators
- Murat K Erdem, PhD, DDS, Study director, Ankara University Faculty of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262841
- Sponsor's protocol ID
- Murat Kaan Erdem
- Status last verified
- Feb 2024
- First submitted
- 1 Feb 2024
- Last updated
- 16 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Rullo R, Addabbo F, Papaccio G, D'Aquino R, Festa VM. Piezoelectric device vs. conventional rotative instruments in impacted third molar surgery: relationships between surgical difficulty and postoperative pain with histological evaluations. J Craniomaxillofac Surg. 2013 Mar;41(2):e33-8. doi: 10.1016/j.jcms.2012.07.007. Epub 2012 Aug 11.
PubMed 22890087Rosa AL, Carneiro MG, Lavrador MA, Novaes AB Jr. Influence of flap design on periodontal healing of second molars after extraction of impacted mandibular third molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Apr;93(4):404-7. doi: 10.1067/moe.2002.122823.
PubMed 12029279Ren YF, Malmstrom HS. Effectiveness of antibiotic prophylaxis in third molar surgery: a meta-analysis of randomized controlled clinical trials. J Oral Maxillofac Surg. 2007 Oct;65(10):1909-21. doi: 10.1016/j.joms.2007.03.004.
PubMed 17884515Piersanti L, Dilorenzo M, Monaco G, Marchetti C. Piezosurgery or conventional rotatory instruments for inferior third molar extractions? J Oral Maxillofac Surg. 2014 Sep;72(9):1647-52. doi: 10.1016/j.joms.2014.04.032. Epub 2014 May 6.
PubMed 25109581Cho H, David MC, Lynham AJ, Hsu E. Effectiveness of irrigation with chlorhexidine after removal of mandibular third molars: a randomised controlled trial. Br J Oral Maxillofac Surg. 2018 Jan;56(1):54-59. doi: 10.1016/j.bjoms.2017.11.010. Epub 2017 Dec 6.
PubMed 29223633Cicciu M, Stacchi C, Fiorillo L, Cervino G, Troiano G, Vercellotti T, Herford AS, Galindo-Moreno P, Di Lenarda R. Piezoelectric bone surgery for impacted lower third molar extraction compared with conventional rotary instruments: a systematic review, meta-analysis, and trial sequential analysis. Int J Oral Maxillofac Surg. 2021 Jan;50(1):121-131. doi: 10.1016/j.ijom.2020.03.008. Epub 2020 Apr 11.
PubMed 32284166Mantovani E, Arduino PG, Schierano G, Ferrero L, Gallesio G, Mozzati M, Russo A, Scully C, Carossa S. A split-mouth randomized clinical trial to evaluate the performance of piezosurgery compared with traditional technique in lower wisdom tooth removal. J Oral Maxillofac Surg. 2014 Oct;72(10):1890-7. doi: 10.1016/j.joms.2014.05.002. Epub 2014 May 13.
PubMed 25234524Sortino F, Pedulla E, Masoli V. The piezoelectric and rotatory osteotomy technique in impacted third molar surgery: comparison of postoperative recovery. J Oral Maxillofac Surg. 2008 Dec;66(12):2444-8. doi: 10.1016/j.joms.2008.06.004.
PubMed 19022121Goyal M, Marya K, Jhamb A, Chawla S, Sonoo PR, Singh V, Aggarwal A. Comparative evaluation of surgical outcome after removal of impacted mandibular third molars using a Piezotome or a conventional handpiece: a prospective study. Br J Oral Maxillofac Surg. 2012 Sep;50(6):556-61. doi: 10.1016/j.bjoms.2011.10.010. Epub 2011 Nov 15.
PubMed 22088359Barone A, Marconcini S, Giacomelli L, Rispoli L, Calvo JL, Covani U. A randomized clinical evaluation of ultrasound bone surgery versus traditional rotary instruments in lower third molar extraction. J Oral Maxillofac Surg. 2010 Feb;68(2):330-6. doi: 10.1016/j.joms.2009.03.053. Epub 2010 Jan 15.
PubMed 20116704Ge J, Yang C, Zheng JW, He DM, Zheng LY, Hu YK. Four osteotomy methods with piezosurgery to remove complicated mandibular third molars: a retrospective study. J Oral Maxillofac Surg. 2014 Nov;72(11):2126-33. doi: 10.1016/j.joms.2014.05.028. Epub 2014 Jun 14.
PubMed 25201232Erdem MK, Cambazoglu M. A comparative analysis of postoperative morbidity and alveolar bone regeneration following surgical extraction of impacted lower third molar teeth using piezosurgery and conventional instruments: a split-mouth clinical investigation. Eur J Med Res. 2024 Sep 14;29(1):460. doi: 10.1186/s40001-024-02051-8.
PubMed 39272144
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Morbidity and Alveolar Bone Healing After Surgical Extraction of Impacted Lower Third Molar Teeth Using Piezosurgery and Conventional Instruments: A Split-Mouth Clinical Study
- ClinicalTrials.gov ID
- NCT06262841
- Acronym / sponsor ID
- Murat Kaan Erdem
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 1 Apr 2023 (actual)
- First posted
- 16 Feb 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 aim of this study is to compare piezosurgery and conventional surgery in impacted third molar surgery and to determine its effect on postoperative outcomes and quality of life.
Detailed description
The aim of our study is to comparatively evaluate the duration of the operation and the pain, trismus, edema and healing of the alveolar bone that occur after tooth extraction in surgical extractions of impacted lower third molar teeth using piezosurgery and traditional rotary instruments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezosurgery group | Experimental | Device: PiezosurgeryIn the experimental group, a piezosurgery device was used to remove the bone surrounding the impacted third molar. Intervention: Device: Piezosurgery |
| Conventional group | Active comparator | Device: Conventional bursIn the control group, conventional burs were used to remove the bone surrounding the impacted third molar. Intervention: Device: Conventional burs |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- ASA I-II
- Aged 18-35
- Symmetrical Class 2 Position B according to Winter and Pell-gregory classification
- Asymptomatic lower third molar tooth with the same difficulty according to the Yuasa difficulty index
Key exclusion criteria (5 listed)
- Individuals who had systemic disease affecting bone or soft tissue metabolism
- Smokers (more than 10 cigarettes a day)
- Alcohol dependent
- Systemic disease affecting bone or soft tissue metabolism
- Acute pericoronitis or acute periodontal disease at the time of operation, and used antibiotics due to acute infection
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 |
|---|---|---|
| PiezosurgeryPiezosurgery used as an osteotomy device | Device | Piezosurgery group |
| Conventional bursConventional burs used as an osteotomy device | Device | Conventional group |
Primary outcome
Change in Oral Health-related Quality of Life
Time frame: Time Frame: 14 days
Evaluated by Oral Health Impact Profile-14 questionnaire (OHIP-14). The OHIP-14 scores can range from 0 to 56 and are calculated by summing the ordinal values for the 14 items. The domain scores can range from 0 to 8. Higher OHIP-14 scores indicate worse and lower scores indicate better Oral Health Related Quality of Life.
4 secondary outcomes
Change in pain
Time frame: 7 days
Change in Mouth opening
Time frame: 7 days
Operation time
Time frame: Intraoperative
Change in facial swelling
Time frame: 7 days
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 16 Feb 2024.
- Results publication: PubMed 22890087Rullo R, Addabbo F, Papaccio G, D'Aquino R, Festa VM. Piezoelectric device vs. conventional rotative instruments in impacted third molar surgery: relationships between surgical difficulty and postoperative pain with histological evaluations. J Craniomaxillofac Surg. 2013 Mar;41(2):e33-8. doi: 10.1016/j.jcms.2012.07.007. Epub 2012 Aug 11.
- Results publication: PubMed 12029279Rosa AL, Carneiro MG, Lavrador MA, Novaes AB Jr. Influence of flap design on periodontal healing of second molars after extraction of impacted mandibular third molars. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Apr;93(4):404-7. doi: 10.1067/moe.2002.122823.
- Results publication: PubMed 17884515Ren YF, Malmstrom HS. Effectiveness of antibiotic prophylaxis in third molar surgery: a meta-analysis of randomized controlled clinical trials. J Oral Maxillofac Surg. 2007 Oct;65(10):1909-21. doi: 10.1016/j.joms.2007.03.004.
- Results publication: PubMed 25109581Piersanti L, Dilorenzo M, Monaco G, Marchetti C. Piezosurgery or conventional rotatory instruments for inferior third molar extractions? J Oral Maxillofac Surg. 2014 Sep;72(9):1647-52. doi: 10.1016/j.joms.2014.04.032. Epub 2014 May 6.
- Results publication: PubMed 29223633Cho H, David MC, Lynham AJ, Hsu E. Effectiveness of irrigation with chlorhexidine after removal of mandibular third molars: a randomised controlled trial. Br J Oral Maxillofac Surg. 2018 Jan;56(1):54-59. doi: 10.1016/j.bjoms.2017.11.010. Epub 2017 Dec 6.
- Results publication: PubMed 32284166Cicciu M, Stacchi C, Fiorillo L, Cervino G, Troiano G, Vercellotti T, Herford AS, Galindo-Moreno P, Di Lenarda R. Piezoelectric bone surgery for impacted lower third molar extraction compared with conventional rotary instruments: a systematic review, meta-analysis, and trial sequential analysis. Int J Oral Maxillofac Surg. 2021 Jan;50(1):121-131. doi: 10.1016/j.ijom.2020.03.008. Epub 2020 Apr 11.
- Results publication: PubMed 25234524Mantovani E, Arduino PG, Schierano G, Ferrero L, Gallesio G, Mozzati M, Russo A, Scully C, Carossa S. A split-mouth randomized clinical trial to evaluate the performance of piezosurgery compared with traditional technique in lower wisdom tooth removal. J Oral Maxillofac Surg. 2014 Oct;72(10):1890-7. doi: 10.1016/j.joms.2014.05.002. Epub 2014 May 13.
- Results publication: PubMed 19022121Sortino F, Pedulla E, Masoli V. The piezoelectric and rotatory osteotomy technique in impacted third molar surgery: comparison of postoperative recovery. J Oral Maxillofac Surg. 2008 Dec;66(12):2444-8. doi: 10.1016/j.joms.2008.06.004.
- Results publication: PubMed 22088359Goyal M, Marya K, Jhamb A, Chawla S, Sonoo PR, Singh V, Aggarwal A. Comparative evaluation of surgical outcome after removal of impacted mandibular third molars using a Piezotome or a conventional handpiece: a prospective study. Br J Oral Maxillofac Surg. 2012 Sep;50(6):556-61. doi: 10.1016/j.bjoms.2011.10.010. Epub 2011 Nov 15.
- Results publication: PubMed 20116704Barone A, Marconcini S, Giacomelli L, Rispoli L, Calvo JL, Covani U. A randomized clinical evaluation of ultrasound bone surgery versus traditional rotary instruments in lower third molar extraction. J Oral Maxillofac Surg. 2010 Feb;68(2):330-6. doi: 10.1016/j.joms.2009.03.053. Epub 2010 Jan 15.
- Results publication: PubMed 25201232Ge J, Yang C, Zheng JW, He DM, Zheng LY, Hu YK. Four osteotomy methods with piezosurgery to remove complicated mandibular third molars: a retrospective study. J Oral Maxillofac Surg. 2014 Nov;72(11):2126-33. doi: 10.1016/j.joms.2014.05.028. Epub 2014 Jun 14.
- Derived from this study: PubMed 39272144Erdem MK, Cambazoglu M. A comparative analysis of postoperative morbidity and alveolar bone regeneration following surgical extraction of impacted lower third molar teeth using piezosurgery and conventional instruments: a split-mouth clinical investigation. Eur J Med Res. 2024 Sep 14;29(1):460. doi: 10.1186/s40001-024-02051-8.
- Individual participant dataSharing planned: Yes
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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.
Murat K Erdem, PhD, DDS study director
Ankara University Faculty of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezosurgery and Conventional burs in people with Impacted Third Molar Tooth, run by Ankara 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 4 inclusion and 5 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 16 Feb 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?
Change in Oral Health-related Quality of Life (time frame: Time Frame: 14 days). 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 NCT06262841, which also lists 12 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 16 Feb 2024.