Impacted Third Molar ToothNCT03784638
Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery
A study testing lingually-based triangle flap design and buccally based triangular flap design in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare the effects of lingually-based triangle flap design and buccally based triangular flap design on postoperative swelling, trismus pain after mandibular third molar surgery. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- lingually-based triangle flap design and buccally based triangular flap design
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Nov 2018to 3 Apr 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- symmetrically positioned impacted bilateral mandibular third molars (mesioangular)
Who cannot join
- pericoronal pathology
- use of medications
- poor oral hygiene
- smoking habit
- pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Necmettin Erbakan University, Faculty of Dentistry
Konya, Karatay, 42050
About this study
The aim of this study was to compare the effects of lingually-based triangle flap design and buccally based triangular flap design on postoperative swelling, trismus pain after mandibular third molar surgery.
Read the detailed description
Investigators planned a prospective and split mouth study. Thirty patients is randomly selected. Inclusion criteria is 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. Exclusion criteria is as follows: Alcohol abuse, smoking, pregnancy and acute severe periodontitis.
All surgeries will be carried out by the same surgeon. For each patient, the impacted teeth will be extracted in two sessions using the two different flap design.One side of the patients was selected and labeled as "experimental group". In this group, investigators will use lingually-based triangle flap design while investigators extract the impacted third molar teeth. Other side was accepted as "control group" and in this group, investigators will use buccally based triangular flap design.
In the experimental group, an incision was made adjacent to the distal surface of the mandibular second molar, and extended along the sulcus to the distobuccal corner of the mandibular second molar. An oblique vestibular incision was made and extended into the vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It was continued posterosuperiorly towards the anterior border of mandibular ramus. In the control group, an incision will be made from the anterior border of the mandibular second molar. It will be extended along the sulcus to the distobuccal corner of the second molar crown. The incision will be continuous with vertical incision.
A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure was accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
After the surgery, the patients will be prescribed a 5-day course of 100 mg flurbiprofen twice daily, 1 gr amoxicillin twice daily and chlorhexidine gluconate- benzydamine hydrochloride antiseptic mouthwash every 8 h.There will be at least one month between two surgeries.
The duration of each procedure from the start of the incision to the time of last suture placement will be noted.
Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth opening, wound dehiscence. For the assesment of the pain, pain scale will be used. For the swelling evaluation, measurement will be done from the different three region on the face.
- Tragus-Pogonion
- Tragus-Labial Commissura
- Angulus Mandible-Lateral canthus
Maximum mouth opening will be noted before and after (one week later) the surgery.
- Conditions
- Impacted Third Molar Tooth
- Being tested
- lingually-based triangle flap design, buccally based triangular flap design
- Keywords
- trismus, pain, edema, flap design
- Medical subject headings
- Trismus, Pain, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lingually-based triangle flap designProcedure or surgery
A mucoperiosteal lingually-based triangle flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
buccally based triangular flap designOther
A mucoperiosteal buccally based triangular flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
| Study group | Role | What they receive |
|---|---|---|
| lingually-based triangle flap design | Experimental | In the experimental group, an incision will be made adjacent to the distal surface of the mandibular second molar, and extended along the sulcus to the distobuccal corner of the mandibular second molar. An oblique vestibular incision will made and extended into the vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It was continued posterosuperiorly towards the anterior border of mandibular ramus. The lingually-based triangle flap design will be used. Receives: Procedure: lingually-based triangle flap design |
| buccally based triangle flap design | Placebo comparator | In the control group, an incision will be made from the anterior border of the mandibular second molar. It will be extended along the sulcus to the distobuccal corner of the second molar crown. The incision will be continuous with vertical incision. The buccally based triangle flap design will be used. Receives: Other: buccally based triangular flap design |
What is being measured
The primary outcome is the main question the study is designed to answer.
For edema, the distances between Tragus-Pogonion, Tragus-Labial Commissure, Angulus Mandibula-Lateral Canthus will be measured preoperatively, postoperative 2nd day, 7th day and 14th day surgery.
The edema measurement will be done preoperatively, postoperative 2nd day, 7th day and 14th day surgery.
Measured: Up to 2 weeks
Secondary outcomes (1)
For the assesment of the pain, pain scale will be used.
The patients will fill the pain scale every day until the seventh day after operation.
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 posted24 Dec 2018
- Study start30 Nov 2018
- Primary completion11 Mar 2019
- Study completion3 Apr 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- lingually-based triangle flap design buccaly-based triangular flap design
- Masking
- None (open label)
- 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, DDS, PhD, Principal investigator, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784638
- Sponsor's protocol ID
- KonyaNEU
- Status last verified
- Sep 2018
- First submitted
- 14 Dec 2018
- Last updated
- 8 Apr 2019
- Results posted
- 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 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery
- ClinicalTrials.gov ID
- NCT03784638
- Acronym / sponsor ID
- KonyaNEU
- Conditions
- Impacted Third Molar Tooth
- Keywords
- trismus, pain, edema, flap design
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Konya Necmettin Erbakan ÜniversitesiUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 11 Mar 2019 (actual)
- Study completion
- 3 Apr 2019 (actual)
- First posted
- 24 Dec 2018 (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 was to compare the effects of lingually-based triangle flap design and buccally based triangular flap design on postoperative swelling, trismus pain after mandibular third molar surgery.
Detailed description
Investigators planned a prospective and split mouth study. Thirty patients is randomly selected. Inclusion criteria is 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. Exclusion criteria is as follows: Alcohol abuse, smoking, pregnancy and acute severe periodontitis.
All surgeries will be carried out by the same surgeon. For each patient, the impacted teeth will be extracted in two sessions using the two different flap design.One side of the patients was selected and labeled as "experimental group". In this group, investigators will use lingually-based triangle flap design while investigators extract the impacted third molar teeth. Other side was accepted as "control group" and in this group, investigators will use buccally based triangular flap design.
In the experimental group, an incision was made adjacent to the distal surface of the mandibular second molar, and extended along the sulcus to the distobuccal corner of the mandibular second molar. An oblique vestibular incision was made and extended into the vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It was continued posterosuperiorly towards the anterior border of mandibular ramus. In the control group, an incision will be made from the anterior border of the mandibular second molar. It will be extended along the sulcus to the distobuccal corner of the second molar crown. The incision will be continuous with vertical incision.
A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure was accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
After the surgery, the patients will be prescribed a 5-day course of 100 mg flurbiprofen twice daily, 1 gr amoxicillin twice daily and chlorhexidine gluconate- benzydamine hydrochloride antiseptic mouthwash every 8 h.There will be at least one month between two surgeries.
The duration of each procedure from the start of the incision to the time of last suture placement will be noted.
Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth opening, wound dehiscence. For the assesment of the pain, pain scale will be used. For the swelling evaluation, measurement will be done from the different three region on the face.
- Tragus-Pogonion
- Tragus-Labial Commissura
- Angulus Mandible-Lateral canthus
Maximum mouth opening will be noted before and after (one week later) the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- lingually-based triangle flap design buccaly-based triangular flap design
| Arm | Type | Receives |
|---|---|---|
| lingually-based triangle flap design | Experimental | Procedure: lingually-based triangle flap designIn the experimental group, an incision will be made adjacent to the distal surface of the mandibular second molar, and extended along the sulcus to the distobuccal corner of the mandibular second molar. An oblique vestibular incision will made and extended into the vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It was continued posterosuperiorly towards the anterior border of mandibular ramus. The lingually-based triangle flap design will be used. |
| buccally based triangle flap design | Placebo comparator | Other: buccally based triangular flap designIn the control group, an incision will be made from the anterior border of the mandibular second molar. It will be extended along the sulcus to the distobuccal corner of the second molar crown. The incision will be continuous with vertical incision. The buccally based triangle flap design will be used. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- symmetrically positioned impacted bilateral mandibular third molars (mesioangular)
Key exclusion criteria (5 listed)
- pericoronal pathology
- use of medications
- poor oral hygiene
- smoking habit
- pregnancy or lactation
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 |
|---|---|---|
| lingually-based triangle flap designA mucoperiosteal lingually-based triangle flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures. | Procedure or surgery | lingually-based triangle flap design |
| buccally based triangular flap designA mucoperiosteal buccally based triangular flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures. | Other | buccally based triangle flap design |
Primary outcome
For edema, the distances between Tragus-Pogonion, Tragus-Labial Commissure, Angulus Mandibula-Lateral Canthus will be measured preoperatively, postoperative 2nd day, 7th day and 14th day surgery.
Time frame: Up to 2 weeks
The edema measurement will be done preoperatively, postoperative 2nd day, 7th day and 14th day surgery.
1 secondary outcome
For the assesment of the pain, pain scale will be used.
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 Apr 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, DDS, PhD principal investigator
Necmettin Erbakan 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 lingually-based triangle flap design and buccally based triangular flap design in people with Impacted Third Molar Tooth, run by Konya Necmettin Erbakan Üniversitesi 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 1 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 8 Apr 2019. 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. 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?
For edema, the distances between Tragus-Pogonion, Tragus-Labial Commissure, Angulus Mandibula-Lateral Canthus will be measured preoperatively, postoperative 2nd day, 7th day and 14th day surgery. (time frame: Up to 2 weeks). 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 Apr 2019.