Aim of the study is to use comma shaped incision for impacted mandibular third molars rather than traditional ward incision because comma incision is expected to be associated with lesser incidence of postoperative pain, swelling and trismus.
Design
A concealed, randomized, blinded controlled clinical trial with a parallel group design of 100 patients, enrolled between 3rd October 2018 to 2nd April 2019 ,and followed for 6 months
Settings and conduct
Non-probability, Consecutive sampling done in dept of Oral and Maxillofacial Surgery, AFID Rawalpindi.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients with fully impacted lower third molars; Patients having physical status 1 according to ASA classification. Exclusion Criteria: Pregnant women, nursing mothers; Patients with non-localized odontogenic infection; Tooth associated with pathologies, Patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases
Intervention groups
Intervention group 1: Surgical removal of impacted mandibular third molar using comma-shaped incision. Intervention group 2: Surgical removal of impacted mandibular third molar using traditional ward incision.
Main outcome variables
Pain; swelling; trismus.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230714058773N2
Registration date:2023-09-03, 1402/06/12
Registration timing:retrospective
Last update:2023-09-03, 1402/06/12
Update count:0
Registration date
2023-09-03, 1402/06/12
Registrant information
Name
Tehmina Maryam
Name of organization / entity
Armed forces institute of dentistry, combined military hospital, Rawalpindi, Pakistan
Country
Pakistan
Phone
+92 333 9576737
Email address
tehminamaryam@hotmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-03, 1397/07/11
Expected recruitment end date
2019-04-02, 1398/01/13
Actual recruitment start date
2018-10-03, 1397/07/11
Actual recruitment end date
2019-04-02, 1398/01/13
Trial completion date
2019-04-04, 1398/01/15
Scientific title
Comparison of standard incision and comma shaped incision for impacted mandibular third molar surgery
Public title
Comparison of standard incision and comma shaped incision for impacted mandibular third molar surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with fully impacted lower third molars (more than two-thirds of the crown covered with alveolar bone evaluated on periapical radiograph or OPG)
Patients having physical status 1 according to American Society of Anesthesiologists (ASA) classification.
Exclusion criteria:
Pregnant women, nursing mothers
Patient with non-localized odontogenic infection
Tooth associated with pathologies i.e. cysts, mandibular angle fractures, tumors
Patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Non-probability, Consecutive sampling was done in startified randomization by allotment of random numbers.Randomization was done by giving Odd numbers to the intervention group and even numbers to the control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of armed forces institute of dentistry CMH Rawalpindi
Street address
Range road Rawalpindi
City
Rawalpindi
Postal code
46000
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
905/Trg-ABP1K2
Health conditions studied
1
Description of health condition studied
Third molar impacted and embedded teeth
ICD-10 code
K01
ICD-10 code description
Embedded and impacted teeth
2
Description of health condition studied
Third molar embedded teeth
ICD-10 code
K01.1
ICD-10 code description
Impacted teeth
Primary outcomes
1
Description
Pain
Timepoint
0 and 1st post operative day
Method of measurement
10 point Visual Analog Scale as None, Weak, Moderate and Severe pain . If VAS ≥ 7 then it was considered pain
2
Description
Post Operative swelling
Timepoint
1st and 3rd post operative day
Method of measurement
Swelling assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion. These readings were taken pre-operatively and compared with the readings taken on 1st and 3rd day post-operatively.
3
Description
Trismus/ mouth opening
Timepoint
0 and 1st post operative day
Method of measurement
Mouth opening measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: A total of 50 cases with fully impacted lower third molars of age 18-45 years and both genders were included. Pregnant women, nursing mothers, patient with non-localized odontogenic infection, tooth associated with pathologies i.e. cysts, mandibular angle fractures, tumors, patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease were excluded. Surgical removal of impacted mandibular third molar was done under local anaesthesia using comma shaped incisions. Postoperative pain experienced by patient after third molar surgery was assessed at 24 hours after extraction on 10 point Visual Analog Scale as None, Weak, Moderate and Severe pain. If VAS ≥ 7 then it was considered pain. Mouth opening was measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm. Swelling was assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion.
Category
Treatment - Surgery
2
Description
Control group: 50 cases with fully impacted lower third molars of age 18-45 years and both genders were included. Pregnant women, nursing mothers, patient with non-localized odontogenic infection, tooth associated with pathologies i.e. cysts, mandibular angle fractures, tumors, patients on radiotherapy, chemotherapy, bisphosphonates, bone diseases e.g. Paget’s disease were excluded. Surgical removal of impacted mandibular third molar was done under local anaesthesia using standard ward flap incision Postoperative pain experienced by patient after third molar surgery was assessed at 24 hours after extraction on 10 point Visual Analog Scale as None, Weak, Moderate and Severe pain. If VAS ≥ 7 then it was considered pain. Mouth opening was measured after 24 hours of surgery as interincisal distance in millimeters and patient had trismus if interincisal mouth opening is less than or equal to 29 mm. Swelling was assessed as distance measured between: Lateral canthus of the eye to the gonion angle; Tragus to the commissure of the mouth; Tragus to pogonion.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Armed forces institute of dentistry CMH ,Rawalpindi ,Pakistan
Full name of responsible person
Tehmina Maryam
Street address
Range road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 333 9576737
Email
tehminamaryam27@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Armed forces institute of dentistry CMH Rawalpindi
Full name of responsible person
Nazir Khan
Street address
Range road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 333 2353267
Email
nazeerkhan996@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed forces institute of dentistry CMH Rawalpindi
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Armed forces institute of dentistry CMH Rawalpindi
Full name of responsible person
Noman Tahir
Street address
Range road Rawalpindi
City
Rawalpindi
Postal code
46000
Phone
+92 333 7992702
Email
dr.noman92@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Armed forces institute of dentistry CMH Rawalpindi
Proportion provided by this source
50
Public or private sector
Private
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
Armed forces institute of dentistry CMH Rawalpindi
Full name of responsible person
Tehmina Maryam
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Armed forces institute of dentistry CMH Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 9576737
Email
Tehminamaryam27@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Armed forces institute of dentistry CMH Rawalpindi
Full name of responsible person
Tehmina Maryam
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Range road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 9576737
Email
Tehminamaryam27@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Armed forces institute of dentistry CMH Rawalpindi
Full name of responsible person
Tehmina Maryam
Position
Registrar
Latest degree
Bachelor
Other areas of specialty/work
Oral and maxillofacial surgery
Street address
Range road Rawalpindi
City
Rawalpindi
Province
Punjab
Postal code
46000
Phone
+92 333 9576737
Email
Tehminamaryam27@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD