Clinical trial NCT04192864: Comparison Between the Lingually Based and the Buccally Based Triangular Flap Design in the Surgical Removal of Impacted Mandibular Third Molars
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth, Impacted
Lead sponsor: University of Alexandria
Sponsor class: OTHER
Collaborators: name: Alexandria University
First posted: 2019-12-10
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 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
Primary purpose: TREATMENT

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Pain using Visual Analogue Scale (VAS)
timeFrame: 7 days
measure: Postoperative Edema
timeFrame: 7 days
measure: Trismus Assessment
timeFrame: 7 days
measure: Wound healing/ Presence of alveolar osteitis
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Dentistry, Alexandria University
Study officials:
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Nesma M El-Atris, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Saeeda Osman, PhD
role: STUDY_CHAIR
affiliation: Faculty of Dentistry, Alexandria University, Egypt
name: Ahmed Swedan, PhD
role: STUDY_CHAIR
References:
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. doi: 10.1016/s0278-2391(97)90172-5.
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. doi: 10.1016/s0278-2391(99)90861-3.
citation: 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.