Impacted Third Molar ToothNCT03857035
COMPARISON OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY
A study testing Piezosurgery group in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi at 2 sites in Turkey (Türkiye).
Trial summary
The purpose is to compare the effects of piezosurgery and conventional rotary instruments on postoperative pain, swelling, trismus and patients' comfort after mandibular third molar surgery. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Piezosurgery group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 4 Feb 2019to 7 May 2019
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.
Who cannot join
- Exclusion criteria were as follows: Alcohol abuse, smoking, pregnancy, and presence of acute severe periodontitis.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Necmettin Erbakan University, Faculty of Dentistry
Konya, Karatay, 42050
Necmettin Erbakan University
Konya, Karatay, 42050
About this study
Official title: A PROSPECTIVE SPLIT MOUTH CLINICAL STUDY: OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY
The purpose is to compare the effects of piezosurgery and conventional rotary instruments on postoperative pain, swelling, trismus and patients' comfort after mandibular third molar surgery.
Read the detailed description
The investigators plan a prospective and split mouth study. Thirty patients will be randomly selected. Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.
One side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery. The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.There will at least one month between two surgeries. The investigators will compare postoperative pain, swelling, trismus and patients' comfort.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Piezosurgery group
- Keywords
- Trismus, piezosurgery, pain, swelling
- Medical subject headings
- Trismus, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Piezosurgery groupOther
Piezosurgery technique will be examined about impacted third molar surgery.
| Study group | Role | What they receive |
|---|---|---|
| Piezosurgery group | Experimental | One side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery. Receives: Other: Piezosurgery group |
| Rotary Instruments Group | Placebo comparator | The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments. Receives: Other: Piezosurgery group |
What is being measured
The primary outcome is the main question the study is designed to answer.
All the patients will be given a form containing verbal rating scale ranging from 0 to 5, showing the degree of swelling.
The edema measurement will be done during the one week after surgery.
Measured: Up to 1 week
Secondary outcomes (2)
Pain will be assessed using a visual analogue scale.
The level of postoperative pain will be evaluated using a 10-cm visual analogue scale , with zero representing no pain and 10 representing excruciating pain. Pain measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.
Measured: Up to 1 week
Trismus will be evaluated using a caliper at maximum mouth opening.
Trismus will be assessed by measuring the maximum interincisal opening (in millimetres) - the distance between the incisal margin of the upper and lower central incisors. Trismus measurement will be done preoperatively, postoperative 2nd day, 7th day after the surgery.
Measured: Up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start4 Feb 2019
- Primary completion7 May 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konya Necmettin Erbakan Üniversitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dilek Menziletoglu, Konya Necmettin Erbakan Üniversitesi
- Investigators
- Dilek Menziletoglu, Dr, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03857035
- Sponsor's protocol ID
- NEU3
- Status last verified
- Feb 2019
- First submitted
- 22 Feb 2019
- Last updated
- 8 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROSPECTIVE SPLIT MOUTH CLINICAL STUDY: OF PIEZOSURGERY AND CONVENTIONAL ROTARY INSTRUMENTS IN IMPACTED THIRD MOLAR SURGERY
- ClinicalTrials.gov ID
- NCT03857035
- Acronym / sponsor ID
- NEU3
- Conditions
- Impacted Third Molar Tooth
- Keywords
- Trismus, piezosurgery, pain, swelling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 7 May 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 27 Feb 2019 (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 purpose is to compare the effects of piezosurgery and conventional rotary instruments on postoperative pain, swelling, trismus and patients' comfort after mandibular third molar surgery.
Detailed description
The investigators plan a prospective and split mouth study. Thirty patients will be randomly selected. Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.
One side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery. The other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments.There will at least one month between two surgeries. The investigators will compare postoperative pain, swelling, trismus and patients' comfort.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Piezosurgery group | Experimental | Other: Piezosurgery groupOne side of the patients will be randomly selected and labeled as "experimental group". In experimental group, impacted third molar will be extracted using piezosurgery. |
| Rotary Instruments Group | Placebo comparator | Other: Piezosurgery groupThe other side will be accepted as "control group". In the control group, impacted third molar will be extracted using conventional rotary instruments. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Inclusion criteria were being older than 18 of age, having asymptomatic bilateral mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully covered with mucosa and bone, and being otherwise medically healthy.
Key exclusion criteria (1 listed)
- Exclusion criteria were as follows: Alcohol abuse, smoking, pregnancy, and presence of acute severe periodontitis.
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 |
|---|---|---|
| Piezosurgery groupPiezosurgery technique will be examined about impacted third molar surgery. | Other | Piezosurgery group, Rotary Instruments Group |
Primary outcome
All the patients will be given a form containing verbal rating scale ranging from 0 to 5, showing the degree of swelling.
Time frame: Up to 1 week
The edema measurement will be done during the one week after surgery.
2 secondary outcomes
Pain will be assessed using a visual analogue scale.
Time frame: Up to 1 week
Trismus will be evaluated using a caliper at maximum mouth opening.
Time frame: Up to 1 week
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 8 May 2019.
- 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.
Dilek Menziletoglu, Dr principal investigator
Necmettin Erbakan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Piezosurgery group in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi at 2 sites 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 1 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 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
All the patients will be given a form containing verbal rating scale ranging from 0 to 5, showing the degree of swelling. (time frame: Up to 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2019.