Tooth, ImpactedNCT06112366
Comparison of Silk Suture and Tissue Adhesive for Wound Closure After Impacted Tooth
A study testing Surgery of impacted mandibular wisdom teeth and Surgery of impacted mandibular wisdom teeth (the other side) in people with Tooth, Impacted and Tooth Diseases, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
This study was administered to 21 female and 9 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After extraction of the impacted teeth, silk sutures were used on one side and cyanoacrylate tissue adhesive on the other side for wound closure. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth, Impacted, Tooth Diseases
- What is being tested?
- Surgery of impacted mandibular wisdom teeth and Surgery of impacted mandibular wisdom teeth (the other side)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 May 2022to 25 Jul 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Volunteers with bilateral fully impacted mandibular wisdom teeth
Who cannot join
- Patients were excluded from the study if they did not understand the clinical procedures of the study,
- Had allergies or intolerance to any of the substances used in the study,
- Patients on anticoagulant or psychiatric treatment,
- Pregnant or breastfeeding,
- Patients using oral contraceptiveswere,
- Diabetic,
- Patients with periodontal disease or active infection,
- Poor oral hygiene
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Teeth Surgery
This study was administered to 21 female and 9 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After extraction of the impacted teeth, silk sutures were used on one side and cyanoacrylate tissue adhesive on the other side for wound closure. The effects of these two materials on patient comfort were investigated.
Read the detailed description
The aim of this study was to compare the effectiveness of tissue adhesive (Periacryl 90) and silk suture in bilateral mandibular impacted wisdom tooth surgery. In the study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as the experimental group, while the other tooth was selected as the control group and the wound was closed with silk suture. The selected side was determined by a closed envelope procedure. After the first impacted tooth extraction, the patient waited until the wound healed and the symptoms disappeared completely, and then the other tooth was extracted. Both extractions were evaluated on days 3 and 7 for wound healing, edema and trismus. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment
- Conditions
- Tooth, Impacted, Tooth Diseases
- Being tested
- Surgery of impacted mandibular wisdom teeth, Surgery of impacted mandibular wisdom teeth (the other side)
- Keywords
- impacted wisdom teeth, tissue adhesive, silk suture
- Medical subject headings
- Tooth, Impacted, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgery of impacted mandibular wisdom teethProcedure or surgery
Also called Surgery of impacted molar teeth
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with saline and the wound edges were sealed with tissue adhesive containing cyanoacrylate.
Surgery of impacted mandibular wisdom teeth (the other side)Procedure or surgery
Also called Surgery of impacted molar teeth
All surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| The study group used tissue adhesive for wound closure after extraction of impacted wisdom teeth | Experimental | In this study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as an experimental group. Receives: Procedure: Surgery of impacted mandibular wisdom teeth |
| Control group used silk sutures after extraction of impacted wisdom teeth | Placebo comparator | Bilateral impacted wisdom teeth of the patients were randomly selected. After the tooth in the experimental group was extracted, the other impacted wisdom tooth was selected as the control group and silk sutures were used for wound closure. Receives: Procedure: Surgery of impacted mandibular wisdom teeth (the other side) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mouth opening measurements
The distance between the incisals of the patient's central teeth at maximal mouth opening.
Measured: 0-28 days
Facial edema
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
Measured: 0-28 days
Wound healing
View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.
Measured: 0-28 days
Visual Analog Scale
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
Measured: 0-28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2023
- Study start20 May 2022
- Primary completion20 Jan 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth, ImpactedStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yuzuncu Yil University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Keskin Tunc, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06112366
- Sponsor's protocol ID
- YYU-04/05.18.2022
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Teeth Surgery
- ClinicalTrials.gov ID
- NCT06112366
- Acronym / sponsor ID
- YYU-04/05.18.2022
- Conditions
- Tooth, Impacted, Tooth Diseases
- Keywords
- impacted wisdom teeth, tissue adhesive, silk suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 Jan 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 1 Nov 2023 (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.
This study was administered to 21 female and 9 male patients. Patients with impacted wisdom teeth on both sides of the mandible were selected. After extraction of the impacted teeth, silk sutures were used on one side and cyanoacrylate tissue adhesive on the other side for wound closure. The effects of these two materials on patient comfort were investigated.
Detailed description
The aim of this study was to compare the effectiveness of tissue adhesive (Periacryl 90) and silk suture in bilateral mandibular impacted wisdom tooth surgery. In the study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as the experimental group, while the other tooth was selected as the control group and the wound was closed with silk suture. The selected side was determined by a closed envelope procedure. After the first impacted tooth extraction, the patient waited until the wound healed and the symptoms disappeared completely, and then the other tooth was extracted. Both extractions were evaluated on days 3 and 7 for wound healing, edema and trismus. Wound healing was evaluated as good, acceptable and poor. VAS (Visual Analog Scale) was used for pain assessment
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The study group used tissue adhesive for wound closure after extraction of impacted wisdom teeth | Experimental | Procedure: Surgery of impacted mandibular wisdom teethIn this study of 30 patients, 21 females and 9 males, 60 fully impacted lower wisdom teeth were extracted bilaterally and in the same position. One of the bilaretal teeth of the patients was randomly selected and tissue adhesive (Periacryl 90) was applied for wound closure as an experimental group. |
| Control group used silk sutures after extraction of impacted wisdom teeth | Placebo comparator | Procedure: Surgery of impacted mandibular wisdom teeth (the other side)Bilateral impacted wisdom teeth of the patients were randomly selected. After the tooth in the experimental group was extracted, the other impacted wisdom tooth was selected as the control group and silk sutures were used for wound closure. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Volunteers with bilateral fully impacted mandibular wisdom teeth
Key exclusion criteria (8 listed)
- Patients were excluded from the study if they did not understand the clinical procedures of the study,
- Had allergies or intolerance to any of the substances used in the study,
- Patients on anticoagulant or psychiatric treatment,
- Pregnant or breastfeeding,
- Patients using oral contraceptiveswere,
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 |
|---|---|---|
| Surgery of impacted mandibular wisdom teethAlso: Surgery of impacted molar teethAll surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with saline and the wound edges were sealed with tissue adhesive containing cyanoacrylate. | Procedure or surgery | The study group used tissue adhesive for wound closure after extraction of impacted wisdom teeth |
| Surgery of impacted mandibular wisdom teeth (the other side)Also: Surgery of impacted molar teethAll surgical procedures were performed by the same surgeon using the standard surgical technique described below. The anesthetic used was 4% articaine with 1:100,000 adrenaline. In all patients, a sulcus incision was made in the lower second molar and an envelope incision in the third molar region, the mucoperiosteal flap was removed, and extraction was performed with a bone elevator and a third molar elevator. If necessary, the impacted molar was incised with a high-speed dental handpiece and a fissure bur. The wound was irrigated with copious amounts of saline, and the wound edges were carefully sutured with simple 4.0 silk braided non-absorbable sutures. | Procedure or surgery | Control group used silk sutures after extraction of impacted wisdom teeth |
Primary outcome
Mouth opening measurements
Time frame: 0-28 days
The distance between the incisals of the patient's central teeth at maximal mouth opening.
Facial edema
Time frame: 0-28 days
Measurement between facial craniometric points (angulus-tragus, angulus-lateral canthus, angulus-nasal base, angulus-lateral canthus, and angulus-pogonion). The number of participants in the split mouth model was 22. A total of 44 impacted teeth were extracted and edema was measured before and 1 week after each extraction.
Wound healing
Time frame: 0-28 days
View of the wound site in the operation area. The REEDA scale was used for the clinical evaluation of the intraoral surgical field. This scale It includes five factors that indicate wound healing: Redness, Edema, Echymosis, Discharge, Approximation. Each of the recovery factors is evaluated by giving scores of 0, 1, 2 and 3 and the sum of the scores obtained as a result of the evaluation of these five categories constitutes the REEDA score. The lowest score is 0 and the highest score is 15.
Visual Analog Scale
Time frame: 0-28 days
A numerical rating scale VAS was used for pain analysis (0=no pain, 10=most severe pain). The pain levels at 24 hours, 48 hours and 1 week after the surgical procedure were recorded on the patient follow-up form by all patients who participated in the study by explaining that there was no pain at the "zero" level and the most severe pain known at the "10" level on the pain scale, which was organized as a 10 cm horizontal line on the prepared forms.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Tooth, Impacted
Not yet recruiting
Esthetic Impact of Different Minimally Invasive Approaches on Hypomineralized Permanent Anterior Teeth
Enamel Hypomineralization, Dental
Not yet recruiting
Impact of Various Acceleration Techniques on En-masse Retraction of Maxillary Anterior Teeth
Accelerate Tooth Movement
Recruiting
Aescin-Based Herbal Extract (Reparil) for Postoperative Sequelae After Mandibular Third Molar Surgery
Postoperative Pain, Facial Swelling
Not yet recruitingObservational study
Russian Version of OHIP-EDENT-19 for Adults With Complete Tooth Loss
Edentulism
Recruiting
Effect of Collagen Membranes on Distal Periodontal Healing of Second Molars After Impacted Mandibular Third Molar Surgery.
Periodontal Defect
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgery of impacted mandibular wisdom teeth and Surgery of impacted mandibular wisdom teeth (the other side) in people with Tooth, Impacted and Tooth Diseases, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
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 1 inclusion and 8 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: finished, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mouth opening measurements (time frame: 0-28 days). 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 1 Nov 2023.