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

NCT04192864 | Completed

• 1 other identifier: Triagnular flap design
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Tooth, Impacted

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Lingually based triangular flap

EXPERIMENTAL

Procedure: Lingually based triangular flap

Buccally based triangular flap

ACTIVE COMPARATOR

Procedure: Buccally based triangular flap

Interventions

Lingually based triangular flap PROCEDURE

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.

Lingually based triangular flap

Buccally based triangular flap PROCEDURE

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.

Buccally based triangular flap

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nourhan M.Aly: lead
• Alexandria University: collaborator

Study Sites (1)

Faculty of Dentistry, Alexandria University

Alexandria, 21512, Egypt

Location

Related Publications (3)

• 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.

  PMID: 9371111 BACKGROUND

• 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.

  PMID: 10555792 BACKGROUND

• 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.

  PMID: 821867 BACKGROUND

MeSH Terms

Conditions

Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Nesma M El-Atris, BDS

  Faculty of Dentistry, Alexandria University, Egypt

  PRINCIPAL INVESTIGATOR

• Saeeda Osman, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

• Ahmed Swedan, PhD

  Faculty of Dentistry, Alexandria University, Egypt

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study was a single blinded trial, where the participants did not know the technique used in each side.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Instructor of Dental Public Health

Model Details: 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 Record Dates

• First Submitted: December 7, 2019
• First Posted: December 10, 2019
• Study Start: October 25, 2018
• Primary Completion: October 13, 2019
• Study Completion: November 25, 2019
• Last Updated: July 28, 2020

Record last verified: 2020-07

Locations

EG (1)