Impacted Third Molar ToothNCT05385679
Comparison of Two Flaps in Surgical Removal of Impacted Lower Third Molar
A study testing Surgical Extraction of lower third molar in people with Impacted Third Molar Tooth, run by Ashutosh Kumar Singh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Impacted Third Molar Tooth
- What is being tested?
- Surgical Extraction of lower third molar
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2022to 2 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Comparison of Two Flaps in Surgical Removal of Impacted Lower Third Molar;a Randomized Comparative Double Blind Study
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.
Read more
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.
Read the 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;
- Angulation (Winter, 1926) of the impacted tooth ; Vertical, Mesioangular, Horizontal, Distoangular
- 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.
- 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
- Conditions
- Impacted Third Molar Tooth
- Being tested
- Surgical Extraction of lower third molar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical Extraction of lower third molarProcedure or surgery
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. Envelope flap and modifications of triangular flap are the two most commonly used flaps in surgical removal of lower third molar.
| Study group | Role | What they receive |
|---|---|---|
| Envelop Flap | Active comparator | An envelope flap designs involves a sulcular incision from the first to the second molar and a distal relieving incision to the mandibular ramus. Receives: Procedure: Surgical Extraction of lower third molar |
| Triangular flap | Active comparator | Triangular flap involves incision from the mandibular ramus to the distobuccal crown edge of the second molar, followed by a perpendicular incision obliquely into the mandibular vestibulum, with a length of about 10 mm. Receives: Procedure: Surgical Extraction of lower third molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time taken for the surgical removal of impacted lower third molar
The operative time taken will be recorded from the point of incision to the point of last suturing in terms of minutes.
Measured: immediately after surgery
postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.
Measured: 1st postoperative day
postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.
Measured: 3rd postoperative day
postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.
Measured: 7th postoperative day
Secondary outcomes (8)
postoperative swelling
Measurement of edema will be done by using three facial lines ie. the tragus distance (point A) to the corner of the mouth (point C) , the tragus distance (point A) to pogonion (point D) and the angular distance (point E) to the lateral angle of the eye (point B). The distance between the three lines is measured in length and the average value is measured. Swelling will be measured as the difference between pre and post operative distance between these points in terms of millimeters.
Measured: 1st postoperative day
postoperative swelling
Measurement of edema will be done by using three facial lines ie. the tragus distance (point A) to the corner of the mouth (point C) , the tragus distance (point A) to pogonion (point D) and the angular distance (point E) to the lateral angle of the eye (point B). The distance between the three lines is measured in length and the average value is measured. Swelling will be measured as the difference between pre and post operative distance between these points in terms of millimeters.
Measured: 3rd postoperative day
postoperative swelling
Measurement of edema will be done by using three facial lines ie. the tragus distance (point A) to the corner of the mouth (point C) , the tragus distance (point A) to pogonion (point D) and the angular distance (point E) to the lateral angle of the eye (point B). The distance between the three lines is measured in length and the average value is measured. Swelling will be measured as the difference between pre and post operative distance between these points in terms of millimeters.
Measured: 7th postoperative day
post operative trismus
Trismus will be measured as the difference in the distance between the incisal edge of the maxillary central incisor to the lower incisor in midline before and after surgery by using vernier caliper in terms of millimeters.
Measured: 1st postoperative day
post operative trismus
Trismus will be measured as the difference in the distance between the incisal edge of the maxillary central incisor to the lower incisor in midline before and after surgery by using vernier caliper in terms of millimeters.
Measured: 3rd postoperative day
post operative trismus
Trismus will be measured as the difference in the distance between the incisal edge of the maxillary central incisor to the lower incisor in midline before and after surgery by using vernier caliper in terms of millimeters.
Measured: 7th postoperative day
dry socket
The occurrence of dry socket will be observed by looking at whether there is an open alveolar bone area and the patient complaining of postoperative pain.
Measured: 3rd postoperative day
dry socket
The occurrence of dry socket will be observed by looking at whether there is an open alveolar bone area and the patient complaining of postoperative pain
Measured: 7th postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jun 2022 (estimated)
- Primary completion2 Mar 2023 (estimated)
- Study completion2 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Impacted Third Molar ToothStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ashutosh Kumar Singh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ashutosh Kumar Singh, College of Medical Sciences Teaching Hospital. Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385679
- Sponsor's protocol ID
- IOM2
- Status last verified
- Jun 2022
- First submitted
- 12 May 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Flaps in Surgical Removal of Impacted Lower Third Molar;a Randomized Comparative Double Blind Study
- ClinicalTrials.gov ID
- NCT05385679
- Acronym / sponsor ID
- IOM2
- Conditions
- Impacted Third Molar Tooth
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Ashutosh Kumar SinghUniversity, hospital or other
- Study start
- 1 Jun 2022 (estimated)
- Primary completion
- 2 Mar 2023 (estimated)
- Study completion
- 2 Mar 2023 (estimated)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
- Angulation (Winter, 1926) of the impacted tooth ; Vertical, Mesioangular, Horizontal, Distoangular
- 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.
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Envelop Flap | Active comparator | Procedure: Surgical Extraction of lower third molarAn envelope flap designs involves a sulcular incision from the first to the second molar and a distal relieving incision to the mandibular ramus. |
| Triangular flap | Active comparator | Procedure: Surgical Extraction of lower third molarTriangular flap involves incision from the mandibular ramus to the distobuccal crown edge of the second molar, followed by a perpendicular incision obliquely into the mandibular vestibulum, with a length of about 10 mm. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical Extraction of lower third molarThe 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. Envelope flap and modifications of triangular flap are the two most commonly used flaps in surgical removal of lower third molar. | Procedure or surgery | Envelop Flap, Triangular flap |
Primary outcome
operative time taken for the surgical removal of impacted lower third molar
Time frame: immediately after surgery
The operative time taken will be recorded from the point of incision to the point of last suturing in terms of minutes.
postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
Time frame: 1st postoperative day
The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.
postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
Time frame: 3rd postoperative day
The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.
postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
Time frame: 7th postoperative day
The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.
8 secondary outcomes
postoperative swelling
Time frame: 1st postoperative day
postoperative swelling
Time frame: 3rd postoperative day
postoperative swelling
Time frame: 7th postoperative day
post operative trismus
Time frame: 1st postoperative day
post operative trismus
Time frame: 3rd postoperative day
post operative trismus
Time frame: 7th postoperative day
dry socket
Time frame: 3rd postoperative day
dry socket
Time frame: 7th postoperative day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical Extraction of lower third molar in people with Impacted Third Molar Tooth, run by Ashutosh Kumar Singh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operative time taken for the surgical removal of impacted lower third molar (time frame: immediately after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.