Back to resultsEvaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Primary Purpose
Impacted Third Molar Tooth
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Polybutester suture
Polypropylene suture
Sponsored by
About this trial
This is an interventional prevention trial for Impacted Third Molar Tooth focused on measuring Polybutester, Polypropylene, Pain, Edema, Trismus
Eligibility Criteria
Inclusion Criteria: Any medication until 2 weeks before the operations, Impacted teeth in mesial and horizontal positions and in class 2 and class B according to Pell & Gregory classification, Asymptomatic impacted teeth. Coming to control and fill in the given and requested forms, Regularly use the given drugs Exclusion Criteria: Systemic disease, Smoking, Pregnancy or breastfeeding, Allergy to the drugs to be used in the study, Using any additional medication that may affect the outcome of the study, Post-operative alveolitis.
Sites / Locations
- Van Yuzuncu Yil University, Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Polybutester
Polypropylene
Arm Description
Polybutester suture is a copolymer of polyglycol terephthalate and polybutylene terephthalate. It is a synthetic, non-resorbable, monofilament suture material. Polybutester is stronger than other monofilaments. Suture memory is poor and packaging does not retain its shape. Therefore, this suture is easier to work with and the knot security is higher. Polybutester suture adapts better to tensile strength than other synthetic sutures. This suture adapts to the increasing wound edema and returns to its original shape when the edema subsides. Also, this suture reduces the risk of hypertrophic scar formation due to its ability to adapt to the edema and changing configuration of a healing wound. It produces better cosmetic results.
Polypropylene, used as suture material, is formed by bringing isotactic stereoisomers of a linear hydrocarbon crystalline polymer into sterile monofilament form. Polymer polypropylene is a non-resorbable, synthetic, monofilament suture. It has high compressive strength and low tissue reactivity. It is resistant to infection formation. In general, the ability to close and protect the wound is good. The suture memory is high, therefore it is difficult to use and the knot security is less than other sutures. Allergic reaction due to polypropylene sutures is very rare.
Outcomes
Primary Outcome Measures
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Pain Evaluation
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Edema evaluation using Facial measurement
The distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.
Edema evaluation using Facial measurement
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.
Edema evaluation
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.
Trismus Evaluation
Preoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which were measured with a caliper.
Trismus evaluation
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Trismus evaluation
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Secondary Outcome Measures
Full Information
NCT ID
NCT05679973
First Posted
February 16, 2022
Last Updated
December 24, 2022
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05679973
Brief Title
Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Official Title
Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl 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
This study aimed to evaluate the efficacy of polybutester sutures on postoperative complications in lower impacted third molar surgery.
Detailed Description
After extraction of the bilateral lower third molars (35 patients), two different types of sutures were used on each side. Group 1( Polybutester suture) , group 2 (Polypropylene suture). Measurements to evaluate edema, trismus, and pain (using the VAS scale) had been taken pre-procedure and post-procedure( 2nd and 7th day )
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
Polybutester, Polypropylene, Pain, Edema, Trismus
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Polybutester
Arm Type
Experimental
Arm Description
Polybutester suture is a copolymer of polyglycol terephthalate and polybutylene terephthalate. It is a synthetic, non-resorbable, monofilament suture material. Polybutester is stronger than other monofilaments. Suture memory is poor and packaging does not retain its shape. Therefore, this suture is easier to work with and the knot security is higher. Polybutester suture adapts better to tensile strength than other synthetic sutures. This suture adapts to the increasing wound edema and returns to its original shape when the edema subsides. Also, this suture reduces the risk of hypertrophic scar formation due to its ability to adapt to the edema and changing configuration of a healing wound. It produces better cosmetic results.
Arm Title
Polypropylene
Arm Type
Active Comparator
Arm Description
Polypropylene, used as suture material, is formed by bringing isotactic stereoisomers of a linear hydrocarbon crystalline polymer into sterile monofilament form. Polymer polypropylene is a non-resorbable, synthetic, monofilament suture. It has high compressive strength and low tissue reactivity. It is resistant to infection formation. In general, the ability to close and protect the wound is good. The suture memory is high, therefore it is difficult to use and the knot security is less than other sutures. Allergic reaction due to polypropylene sutures is very rare.
Intervention Type
Device
Intervention Name(s)
Polybutester suture
Intervention Description
After third molar surgery this suture used for primary closure.
Intervention Type
Device
Intervention Name(s)
Polypropylene suture
Intervention Description
After third molar surgery this suture used for primary closure.
Primary Outcome Measure Information:
Title
Pain Evaluation
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 1st day
Title
Pain Evaluation
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 2nd day
Title
Pain Evaluation
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 3rd day
Title
Pain Evaluation
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 5th day
Title
Pain Evaluation
Description
Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).
Time Frame
Postoperative 7th day
Title
Edema evaluation using Facial measurement
Description
The distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.
Time Frame
Preoperative
Title
Edema evaluation using Facial measurement
Description
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.
Time Frame
Postoperative 2nd day
Title
Edema evaluation
Description
Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, from tragus to labial commissura, and from tragus to soft tissue pogonion) which was measured with using thread and millimeter ruler.
Time Frame
Postoperative 7th day
Title
Trismus Evaluation
Description
Preoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which were measured with a caliper.
Time Frame
Preoperative
Title
Trismus evaluation
Description
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time Frame
Postoperative 2nd day
Title
Trismus evaluation
Description
Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.
Time Frame
Postoperative 7th day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any medication until 2 weeks before the operations,
Impacted teeth in mesial and horizontal positions and in class 2 and class B according to Pell & Gregory classification,
Asymptomatic impacted teeth.
Coming to control and fill in the given and requested forms,
Regularly use the given drugs
Exclusion Criteria:
Systemic disease,
Smoking,
Pregnancy or breastfeeding,
Allergy to the drugs to be used in the study,
Using any additional medication that may affect the outcome of the study,
Post-operative alveolitis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Levent Ciğerim, Assoc.Prof.
Organizational Affiliation
Van Yuzuncu Yil University
Official's Role
Study Director
Facility Information:
Facility Name
Van Yuzuncu Yil University, Faculty of Dentistry
City
Van
ZIP/Postal Code
65080
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Efficacy of Polybutester Suture on Postoperative Complications in Lower Impacted Third Molar Surgery
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