Clinical trial NCT05385679: Comparison of Two Flaps in Surgical Removal of Impacted Lower Third Molar
Official title: Comparison of Two Flaps in Surgical Removal of Impacted Lower Third Molar;a Randomized Comparative Double Blind Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Impacted Third Molar Tooth
Lead sponsor: College of Medical Sciences Teaching Hospital. Nepal
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Project summary

The surgical removal of mandibular third molar is one of the most common procedures done in oral and maxillofacial surgery. Patients often experience pain, swelling, trismus, dehiscence, alveolar osteitis, infection, nerve injury and periodontal tissue damage after third molar surgery. Flap design is an important step in third molar surgery.The aim of this study is to compare the triangular and envelope flap designs in lower third molar surgery in terms of postoperative sequelae including pain ,trismus,swelling,incidence of dry socket and also operative time taken.The study also aims to find out does the level of impacted mandibular third molar and number of roots has effect on postoperative outcomes in surgical removal of mandibular third molar.The study design used will be a double-blind randomized clinical study. Patients who fit the inclusion criteria will be included as research subjects.Sample will be divided into two groups randomly. In one group the envelope flap will be raised during surgical removal of the lower third molar while in the other triangular flap will be used.

Investigators will also divide the third molars into level 1,level 2,level 3 based on the relationship between the tip of mesial cusp of impacted third molar and the distal surface of crown of adjacent second molar based on orthopantomograph findings.Level 1 will be when the tip of mesial cusp of third molar is within the occlusal third of crown of second molar,level 2 will be when the tip of mesial cusp of third molar is within the middle third of crown of second molar, level 3 will be when the tip of mesial cusp of third molar is within and below the cervical third of crown of second molar.

Another subgroup will be based on the number of roots of the impacted third molar where investigators will divide the third molar into single rooted and multirooted based on orthopantomograph findings.

Investigators will also divide the sample based on gender and age group as below 30 years and above 30 years.

The primary outcomes to be measured are pain and operative time while secondary outcomes are swelling ,trismus and incidence of dry socket.Outcome assessment will be done by another clinician than surgeon using scientific tools and techniques as mentioned.

Surgical procedures and outcomes measurement will be done by separate clinicians to ensure masking.

Detailed description: Andreasen et al (1997) defines impaction as a cessation of the eruption of a tooth caused by a clinically or radiographically detectable physical barrier in the eruption path or by an ectopic position of the tooth. The prevalence of third molar impaction ranges from 16.7% to 68.6%. Common pathologies associated with third molars are pericoronitis, caries of impacted teeth or adjacent tooth, second molar tooth resorption, periodontal bone loss of adjacent tooth and odontogenic cysts. The surgical removal of mandibular third molar is one of the most common procedures done in oral and maxillofacial surgery. Flap design is an important step in third molar surgery.Commonly used flap in surgical removal of third molar are envelope flap and triangular flap with modifications.

A number of classifications have been developed for impacted third molars.The most widely used are;

1. Angulation (Winter, 1926) of the impacted tooth ; Vertical, Mesioangular, Horizontal, Distoangular
2. Relationship of the impacted tooth to the anterior border of the ramus (Pell and Gregory, 1942); Class I: Sufficient space available anterior to the anterior border of ramus for the third molar to erupt.

   Class II: Space available is less than the mesio distal width of the crown of the third molar Class III: All or most of the third molar is located within the ramus.
3. Depth of impaction (Pell and Gregory Classification based on relationship to occlusal plane); Position A: The highest portion of the tooth (occlusal plane) is on a level with or above the occlusal line.

Position B: The highest portion of the tooth is below the occlusal line but above the cervical line of the second molar.

Position C: The highest portion of the tooth is below the cervical line of the second molar.

Rationale and justifications of study

The surgical removal of mandibular third molar is one of the most common procedure done in oral and maxillofacial surgery and often associated with pain, swelling, trismus, dehiscence, alveolar osteitis, infection, nerve injury and periodontal tissue damage.Flap design is an important step in this procedure.

The present study is aimed at comparing the envelope and triangular flap in lower third molar surgery based on postoperative outcomes.The study also aims to find does the number of roots and also the relation between level of mesial cusp tip of impacted lower third molar and distal surface of adjacent second molar has any effect on postoperative sequelae.

Although much research was done so far on this topic,further studies were suggested .

Both envelope and triangular flaps are routinely used in lower third molar surgery.So,this study claims no extra medical risks related to the intervention.Patients and investigators bear no extra economic burden in investigations and research.

Objectives

General:

To compare the triangular and envelope flap in surgical removal of vertical and mesioangular impacted lower third molar.

Specific:

To evaluate whether the relation between level of mesial cusp tip of impacted third molar to the distal surface of adjacent second molar has any effect on the post operative outcomes independent of flap designs.

To evaluate the effect of the number of roots of impacted third molar to the postoperative outcomes in third molar surgery independent of flap designs.

Research hypothesis

Null hypothesis: There is no difference between the envelope and triangular flap in terms of post operative outcomes in surgical removal of vertical and mesioangular impacted mandibular third molar.

Alternate hypothesis:There is significant difference between envelope and triangular flap in terms of post operative outcomes in surgical removal of vertical and mesioangular impacted mandibular third molar.

Research design and methodology

Research method Quantitative

Type of study Experimental, double blinded, randomized comparaive study,

Study population Patient visiting department of oral and maxillofacial surgery in TUTH

Study site and its justification Large number of patients visit oral surgery department in TUTH.Most of them visit for surgical removal of impacted mandibular third molar and surgical extraction is commonly performed here.So oral and maxillofacial surgery OPD of TUTH will be ideal site for study as adequate sample size will be available without economic burden to the patient and investigator.

Sampling method Sampling method :Simple random sampling Randomisation will be done by random draw computer method Allocation concealment will be maintained using a sealed opaque envelope.

Sample size

Sample size will be calculated as; Sample size=2SD2(Z

Eligibility criteria: Inclusion Criteria:

* Age between 18-50 years
* No systemic illness and not taking any regular medications
* No signs of local inflammation
* Mesioangular and vertically impacted lower third molar
* Not under antibiotics for at least 3 days before surgery

Exclusion Criteria:

* With known systemic illness
* Those taking regular medications
* Presenting with pain and swelling at the time of surgery
* Impactions other than mesioangular and vertical impactions of lower third molar
* Under antibiotics within 3 days of surgical procedure
* Those having habit of cigarette smoking and females taking oral contraceptives

Primary outcomes:
measure: operative time taken for the surgical removal of impacted lower third molar
timeFrame: immediately after surgery
measure: postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
timeFrame: 1st postoperative day
measure: postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
timeFrame: 3rd postoperative day
measure: postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
timeFrame: 7th postoperative day
Secondary outcomes:
measure: postoperative swelling
timeFrame: 1st postoperative day
measure: postoperative swelling
timeFrame: 3rd postoperative day
measure: postoperative swelling
timeFrame: 7th postoperative day
measure: post operative trismus
timeFrame: 1st postoperative day
measure: post operative trismus
timeFrame: 3rd postoperative day
measure: post operative trismus
timeFrame: 7th postoperative day
measure: dry socket
timeFrame: 3rd postoperative day
measure: dry socket
timeFrame: 7th postoperative day
Other outcomes:
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Study officials:
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