Comparison Between the Lingually Based and the Buccally Based Triangular Flap Design in the Surgical Removal of Impacted Mandibular Third Molars
Primary Purpose
Tooth, Impacted
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lingually based triangular flap
Buccally based triangular flap
Sponsored by
About this trial
This is an interventional treatment trial for Tooth, Impacted
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
Sites / Locations
- Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Lingually based triangular flap
Buccally based triangular flap
Arm Description
Outcomes
Primary Outcome Measures
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)
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
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04192864
First Posted
December 7, 2019
Last Updated
July 25, 2020
Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04192864
Brief Title
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
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
October 25, 2018 (Actual)
Primary Completion Date
October 13, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nourhan M.Aly
Collaborators
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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
Masking
Participant
Masking Description
This study was a single blinded trial, where the participants did not know the technique used in each side.
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lingually based triangular flap
Arm Type
Experimental
Arm Title
Buccally based triangular flap
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lingually based triangular flap
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Buccally based triangular flap
Intervention Description
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.
Primary Outcome Measure Information:
Title
Postoperative Pain using Visual Analogue Scale (VAS)
Description
Pain was assessed through on a 10-point Visual Analogue Scale (VAS). (0-1= None, 2-4= Mild, 5-7= Moderate, 8-10= Severe)
Time Frame
7 days
Title
Postoperative Edema
Description
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
Time Frame
7 days
Title
Trismus Assessment
Description
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.
Time Frame
7 days
Title
Wound healing/ Presence of alveolar osteitis
Description
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.
Time Frame
21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nesma M El-Atris, BDS
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Saeeda Osman, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Ahmed Swedan, PhD
Organizational Affiliation
Faculty of Dentistry, Alexandria University, Egypt
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21512
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
9371111
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.
Results Reference
background
PubMed Identifier
10555792
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.
Results Reference
background
PubMed Identifier
821867
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.
Results Reference
background
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Comparison Between the Lingually Based and the Buccally Based Triangular Flap Design in the Surgical Removal of Impacted Mandibular Third Molars
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