Comparison Between the Lingually Based and the Buccally Based Triangular Flap Design in the Surgical Removal of Impacted Mandibular Third Molars

Comparison Between the Lingually Based and the Buccally Based Triangular Flap Design in the Surgical Removal of Impacted Mandibular Third Molars (Randomized Split Mouth Clinical Trial)

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.

Study Overview

• Status: Completed
• Conditions: Tooth, Impacted
• Intervention / Treatment: Procedure: Lingually based triangular flap; Procedure: Buccally based triangular flap

Detailed 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

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt, 21512
    • Faculty of Dentistry, Alexandria University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 30 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lingually based triangular flap	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.
ACTIVE_COMPARATOR: Buccally based triangular flap	Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Nourhan M.Aly
• Collaborators: Alexandria University
• Investigators: Principal Investigator: Nesma M El-Atris, BDS, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Saeeda Osman, PhD, Faculty of Dentistry, Alexandria University, Egypt; Study Chair: Ahmed Swedan, PhD, Faculty of Dentistry, Alexandria University, Egypt

Publications and helpful links

General Publications

• 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. doi: 10.1016/s0278-2391(97)90172-5.
• 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. doi: 10.1016/s0278-2391(99)90861-3.
• 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. doi: 10.1016/s0300-9785(76)80037-3.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 25, 2018
• Primary Completion (ACTUAL): October 13, 2019
• Study Completion (ACTUAL): November 25, 2019

Study Registration Dates

• First Submitted: December 7, 2019
• First Submitted That Met QC Criteria: December 7, 2019
• First Posted (ACTUAL): December 10, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 25, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth, Impacted
• Other Study ID Numbers: Triagnular flap design

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No