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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04192864
Other study ID # Triagnular flap design
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 25, 2018
Est. completion date November 25, 2019

Study information

Verified date July 2020
Source University of Alexandria
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study was to compare between the lingually based triangular flap with the buccally based triangular flap in the surgical removal of impacted mandibular third molars.


Description:

Many flap designs used for impacted third molar surgery do not place the mucoperosteal incision on sound bone, as they involve incisions that are placed on the extraction socket resulting in higher incidence of mucosal dehiscence, followed by secondary wound healing

This study involved 20 patient with bilaterally mesially angulated impacted third molar (class II position B). One side was surgically removed using the lingually based triangular flap and the other side was surgically removed using the bucally based triangular flap


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 25, 2019
Est. primary completion date October 13, 2019
Accepts healthy volunteers No
Gender All
Age group 21 Years to 30 Years
Eligibility Inclusion Criteria:

Presence of impacted third molar that is misally angulated and retained in bone (class II position B).

Exclusion Criteria:

- Patients with a history of systemic disease (diabetes, renal failure, immunocompromised patients, cardiac patients and patients taking radiotherapy or chemotherapy )

- Compromised dental and periodontal status

- Heavy Smoking.

- Pregnancy or lactation

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Lingually based triangular flap
A lingually based triangular flap was used to remove the impacted third molar. 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 posterosuperior towards the anterior border of the mandibular ramus An incision will be made from the anterior border of the mandibular ramus to the distal surface of the mandibular second molar.
Buccally based triangular flap
The impacted teeth was removed using a buccal based triangular flap. It will be extended along the sulcus to the distobuccal corner of the second molar . The incision was continuous, with a relieving vertical incision, oblique into the mandibular vestibular fornix, aligned with the mesiobuccal cusp of the second molar.

Locations

Country Name City State
Egypt Faculty of Dentistry, Alexandria University Alexandria

Sponsors (2)

Lead Sponsor Collaborator
Nourhan M.Aly Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

Azaz B, Shteyer A, Piamenta M. Radiographic and clinical manifestations of the impacted mandibular third molar. Int J Oral Surg. 1976 Aug;5(4):153-60. — View Citation

Conrad SM, Blakey GH, Shugars DA, Marciani RD, Phillips C, White RP Jr. Patients' perception of recovery after third molar surgery. J Oral Maxillofac Surg. 1999 Nov;57(11):1288-94; discussion 1295-6. — View Citation

Garcia Garcia A, Gude Sampedro F, Gandara Rey J, Gallas Torreira M. Trismus and pain after removal of impacted lower third molars. J Oral Maxillofac Surg. 1997 Nov;55(11):1223-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative Pain using Visual Analogue Scale (VAS) Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe) 7 days
Primary Postoperative Edema For the objective evaluation of swelling, five distances were measured
The distance from the mandibular angle to the lateral corner of the mouth
The distance from the mandibular angle to the nasal alar curvature
The distance from the mandibular angle to the lateral canthus of the eye
The distance from the tragus to the soft tissue pogonion
The distance from the tragus to the lateral corner f the mouth
7 days
Primary Trismus Assessment Trismus was assessed by measuring the maximum inter-incisional opening (in millimeters) the distance between the incisal edge of the upper and lower central incisor using caliber. 7 days
Primary Wound healing/ Presence of alveolar osteitis The presence of alveolar osteitis (dry socket) will be determined clinically using BLUM'S criteria. Wound healing was assessed and recorded depending on the absence or presence of dehiscence, every opening along the incision will be recorded as dehiscence , dental tweezers will be used to identify it. 21 days
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