Trapezoidal Flap vs. Envelope Flap in Mandibular Third Molar Extraction.

Impacted Third Molar Tooth Clinical Trial

Official title:

Trapezoidal Flap Versus Envelope Flap in Impacted Mandibular Third Molar Extraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02120131
• Other study ID #: pcttm
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: April 17, 2014
• Start date: February 2012
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: University of Firenze and Siena, Napoli, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: March 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• third molar impaction

• mild symptoms of pericoronitis

Exclusion Criteria:

• systemic diseases

• cigarettes smoking

• history of irradiation therapy

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Locations

Country	Name	City	State
Italy	Tuscan School of Dentistry	Siena

Sponsors (1)

Lead Sponsor	Collaborator
University of Firenze and Siena, Napoli, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline on the periodontal status of adjacent second molar		6 months	Yes
Secondary	post surgical complication		2 weeks	Yes