Comparative Evaluation of Two Different Envelope Flap Designs on Postoperative Outcomes in the Surgical Removal of Bilateral Impacted Mandibular Third Molar
Since Envelope Flap in most of the Impacted Wisdom teeth Surgery is the Choice of Many Surgeons to Reduce Trauma and Reduce Suturs and because Many Studies have Compared the Effects of Envelop flap and Triangular flap, There is no Comparative study between the Short and Common Envelope flaps. This Study was Conducted to Compare the Effect short Envelope flap and common Envelope flap on post-operative complications of Bilateral Impacted Mandibular third Molar Surgery .
Design
This Research is based on a Single Blind and a Randomized Clinical Trial
Settings and conduct
The Subjects were Aelected from Patients referring to Ahvaz Jundishapur Dentistry Department in 1398-99
Participants/Inclusion and exclusion criteria
All patients were Indications of bilateral Impacted Mandibular third molar Surgery . Patients were not included in the study if they were subject to the following conditions.
1. Acute or chronic periapical Inflammation 2. Systemic Problems or use of Srugs that affect Wound Healing 3. Pregnancy 4. Pericoronitis 5. teeth that had a Major Difference in the Degree of Impaction either Side of the Patient.
If the Patient is not Followed up for Re-examination, the patient is Excluded from the Study
Intervention groups
The Control Group (the Common Envelope Flap) and the Case Group (Short Envelop flap) are Examined in one Patient and at the two sides of Mandible. Two teeth Extracted with an Interval of 14 Days, which Patients are Randomly Assigned to two groups
Main outcome variables
Pain was Determined using Visual Analog Scal and Facial Swelling was evaluated using a Tape Measuring method. Trismus was Determined by Measuring Maximum Interincisal Opening
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181117041685N1
Registration date:2020-03-14, 1398/12/24
Registration timing:registered_while_recruiting
Last update:2020-03-14, 1398/12/24
Update count:0
Registration date
2020-03-14, 1398/12/24
Registrant information
Name
Arman Babadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3337 9113
Email address
ad232223@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-29, 1398/10/08
Expected recruitment end date
2020-04-18, 1399/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Evaluation of Two Different Envelope Flap Designs on Postoperative Outcomes in the Surgical Removal of Bilateral Impacted Mandibular Third Molar
Public title
Effect of Flap Designs on Postoperative Outcomes in the Surgical Removal of Impacted Mandibular Third Molar
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Bilateral Impacted Mandibular Third Molar
All of third molars based on Pell and Gregory were in the A, B, C group and Class 1 or 2 And angle of impaction was mesioangular, vertical, horizontal, or distoangular
Patients Age Were 16-35 years old
Exclusion criteria:
Presence of Acute or Chronic Periapical inflammation
Presence of Systemic Disease
Taking Medications that Affect Wound Healing
Pregnancy
Presence of Pericoronitis
Teeth that Have a Major Difference in the Degree of Impaction on the Sides of a Patient
Tooth that Have a Very Deep lmpaction
Age
From 16 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
66
More than 1 sample in each individual
Number of samples in each individual:
2
Each patient has 2 impacted wisdom teeth
Randomization (investigator's opinion)
Randomized
Randomization description
Blocked randomization
Blinding (investigator's opinion)
Single blinded
Blinding description
just Participants are unaware of the allocation of study groups
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Dental Faculty of Jondishapour university
Street address
Esfand ave Golestan
City
Ahvaz
Province
Khouzestan
Postal code
5326841265
Approval date
2019-12-28, 1398/10/07
Ethics committee reference number
it.ajums.rec.1398.705
Health conditions studied
1
Description of health condition studied
Bilateral impacted mandibular third molar
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Postoperative Pain
Timepoint
The Second and the Seventh Days After Surgery
Method of measurement
Visual Analog Scale
2
Description
maximum Mouth Opening after Surgery
Timepoint
Before Surgery ,The Second and the Seventh Days After Surgery
Method of measurement
Measuring the Distance Between the Upper and Lower Anterior Teeth with the Ruler
3
Description
Occurance of Dry Socket After Surgery
Timepoint
The Second and the Seventh Days after Surgery
Method of measurement
occurrence of Dry Socket with the Onset of Severe Pain from the Second or Third day and Clinical Symptoms of the Socket will Diagnose
Secondary outcomes
1
Description
The Amount of Swelling
Timepoint
Before Surgery ,The Second and the Seventh Days After Surgery
Method of measurement
Postoperative Swelling was Measured as an Observational Evaluation. The Distance Between Tragus -Alar of Nose (A), the Distance between the Tragus - Oral Commissure (B) and Tragus - Soft Tissue of Pogonion (c) is as Follows: Patient is Straight and Sit at a 90 Degree and the Jaw is at Rest
2
Description
Maximum Mouth Opening
Timepoint
Before Surgery ,The Second and the Seventh Days after Surgery
Method of measurement
Measuring the Distance Between the Upper and Lower Anterior Teeth with the Ruler
3
Description
Postoperative Pain
Timepoint
The Second and the Seventh Days after Surgery
Method of measurement
Visual Analog Scale
4
Description
Incidence of Dry Socket
Timepoint
The Second and the Seventh Day after Surgery
Method of measurement
Occurrence of a Dry Socket with the Onset of Severe Pain from the Second or Third Day and Clinical Symptoms of the Socket will diagnose
Intervention groups
1
Description
Intervention group: short envelope flap contains sulcular incision from mesial of mandibular second molar without involving interdental papilla , to disto buccal angel of second molar and extending the incision toward the anterior rim of ramus
Category
Treatment - Surgery
2
Description
Control group: commen envelope flap contains sulcular incision from mesial of mandibular first molar without involving interdental papilla , to disto buccal angel of second molar and extending the incision toward the anterior rim of ramus
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Jondishapour Dental faculty of Ahvaz
Full name of responsible person
Kazem Khiabani Savjebalaghchi
Street address
Dey Ave., Goldstan., Jondishapour dental facility
City
Ahvaz
Province
Khouzestan
Postal code
5245684267
Phone
+98 61 3555 7752
Email
Khiabani_ak@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem Savjebalaghchi Khiabani
Street address
Esfand ave . Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6325874563
Phone
+98 61 3555 7752
Email
khiabani_ak@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem Aavjebalaghchi Khiabani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oral and Maxillofacial Surgery
Street address
Esfand Ave. Golestan
City
Ahvaz
Province
Khouzestan
Postal code
8651124386
Phone
+98 912 101 7048
Email
khiabani_ak@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem savjebalaghchi khiabani
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Oral maxillofacial surgery
Street address
Esfand Ave. Goleztan
City
Ahvaz
Province
Khouzestan
Postal code
1452368745
Phone
+98 912 101 7048
Email
Khiabani_ak@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Kazem Savjebalaghchi khiabani
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Oromaxilofacial surgen
Street address
Dey Ave,. Golestan
City
Ahvaz
Province
Khouzestan
Postal code
4568523459
Phone
+98 912 101 7048
Email
ad232223@Gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available