Impacted Third Molar ToothNCT02120131
Trapezoidal Flap vs. Envelope Flap in Mandibular Third Molar Extraction.
An observational study of Impacted Third Molar Tooth, run by University of Firenze and Siena, Napoli, Italy at 1 site in Italy.
Trial summary
the purpose of this study was to test the effectiveness of the envelope flap compared to trapezoidal flap in impacted mandibular third molar extractions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- How many people
- 52 participants
- Where
- 1 siteItaly
- Study dates
- Feb 2012to Mar 2014
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: a sample of 50 patients requiring mandibular third molar extracion was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study
Who may be able to join
- third molar impaction
- mild symptoms of pericoronitis
Who cannot join
- systemic diseases
- cigarettes smoking
- history of irradiation therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trapezoidal Flap Versus Envelope Flap in Impacted Mandibular Third Molar Extraction
the purpose of this study was to test the effectiveness of the envelope flap compared to trapezoidal flap in impacted mandibular third molar extractions.
Read the detailed description
a sample of 50 patients requiring mandibular third molar extraction was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study. A total number of 52 consecutive cases of mandibular third molar surgical extractions were performed using either a trapezoidal flap or an envelope flap. The choice of the flap was randomized. The following parameters were recorded: Probing Pocket Depth, Clinical Attachment Level, Bleeding on Probing, Full Mouth Plaque Score, Full Mouth Bleeding Score, total time for the surgical intervention, age of the patient, type of inclusion, ostectomy. All the patients received a questionnaire to evaluate the post-intervention discomfort (swelling, pain, number of pain-killers, bleeding). Periodontal parameters were checked at 6-month follow up.
- Conditions
- Impacted Third Molar Tooth
- Keywords
- third molar surgery, periodontal probing depth , flap design
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| test envelope | envelope flap | |
| control, trapezodal | standard incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
change from baseline on the periodontal status of adjacent second molar
Measured: 6 months
Secondary outcomes (1)
post surgical complication
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2014 (estimated)
- Study startFeb 2012
- Primary completionSep 2013
- Study completionMar 2014
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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Firenze and Siena, Napoli, Italy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, nicola baldini, University of Firenze and Siena, Napoli, Italy
- Investigators
- nicola nb baldini, oral surgeon, Principal investigator, tuscan scool of dental medicine of florence and siena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02120131
- Sponsor's protocol ID
- pcttm
- Status last verified
- Apr 2014
- First submitted
- 15 Apr 2014
- Last updated
- 22 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trapezoidal Flap Versus Envelope Flap in Impacted Mandibular Third Molar Extraction
- ClinicalTrials.gov ID
- NCT02120131
- Acronym / sponsor ID
- pcttm
- Conditions
- Impacted Third Molar Tooth
- Keywords
- third molar surgery, periodontal probing depth , flap design
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Firenze and Siena, Napoli, ItalyUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 22 Apr 2014 (estimated)
- 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 of this study was to test the effectiveness of the envelope flap compared to trapezoidal flap in impacted mandibular third molar extractions.
Detailed description
a sample of 50 patients requiring mandibular third molar extraction was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study. A total number of 52 consecutive cases of mandibular third molar surgical extractions were performed using either a trapezoidal flap or an envelope flap. The choice of the flap was randomized. The following parameters were recorded: Probing Pocket Depth, Clinical Attachment Level, Bleeding on Probing, Full Mouth Plaque Score, Full Mouth Bleeding Score, total time for the surgical intervention, age of the patient, type of inclusion, ostectomy. All the patients received a questionnaire to evaluate the post-intervention discomfort (swelling, pain, number of pain-killers, bleeding). Periodontal parameters were checked at 6-month follow up.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test envelope | – | –envelope flap |
| control, trapezodal | – | –standard incision |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- a sample of 50 patients requiring mandibular third molar extracion was selected for the study. Healthy patients with mild symptoms of pericoronitis affecting at least 1 mandibular third molar were included in the study
Key inclusion criteria (2 listed)
- third molar impaction
- mild symptoms of pericoronitis
Key exclusion criteria (3 listed)
- systemic diseases
- cigarettes smoking
- history of irradiation therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
change from baseline on the periodontal status of adjacent second molar
Time frame: 6 months
1 secondary outcome
post surgical complication
Time frame: 2 weeks
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 22 Apr 2014.
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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.
nicola nb baldini, oral surgeon principal investigator
tuscan scool of dental medicine of florence and siena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Impacted Third Molar Tooth, run by University of Firenze and Siena, Napoli, Italy at 1 site in Italy.
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 2 inclusion and 3 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 22 Apr 2014. 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 Italy. 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 from baseline on the periodontal status of adjacent second molar (time frame: 6 months). 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 22 Apr 2014.