Impacted Mandibular Third Molar ExtractionNCT06811974
Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Mandibular Impacted Wisdom Surgery
A study testing Impacted lower wisdom tooth extraction in people with Impacted Mandibular Third Molar Extraction, run by Yuzuncu Yil University at 1 site in Turkey (Türkiye).
Trial summary
In this study, bilateral It is aimed to compare the efficacy of tissue adhesive (Periacryl 90) and silk suture in mandibular impacted wisdom tooth surgery. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Impacted Mandibular Third Molar Extraction
- What is being tested?
- Impacted lower wisdom tooth extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2022to 30 Apr 2024
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Healthy individuals aged 18-35 years who accepted the study conditions and had bilateral, bone or mucosal retention, and completely impacted wisdom teeth in the similar position with an indication for extraction due to prophylactic or orthodontic treatment in the lower jaw were included in the study.
Who cannot join
- Individuals with any systemic disease
- Individuals with a history of allergy to the drugs to be used in the study
- Pregnant and breastfeeding individuals
- Individuals with pain, swelling or trismus in the last 10 days
- Individuals with different positions on the right and left sides
- Individuals who did not sign the voluntary consent form
- Individuals with pathology in the impacted tooth area
- Individuals with limited mouth opening
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi
Van, 65080
About this study
Official title: Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Bilateral Mandibular Impacted Wisdom Dental Surgery
In this study, bilateral It is aimed to compare the efficacy of tissue adhesive (Periacryl 90) and silk suture in mandibular impacted wisdom tooth surgery.
Read the detailed description
In the study carried out on a total 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 bilateral bilateral 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 determined as the control group and the wound was closed with silk suture. The selected party was determined by the closed envelope method. After the first impacted tooth was extracted, it was waited until the wound healed and the symptoms disappeared completely, then the other tooth was extracted. In both tooth extractions, wound healing, edema and trismus were evaluated on the 3rd and 7th days. Wound healing was evaluated as good, acceptable and bad. VAS (Visual Analog Scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.
- Being tested
- Impacted lower wisdom tooth extraction
- Keywords
- tissue adhesive, impacted wisdom tooth, silk suture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impacted lower wisdom tooth extractionProcedure or surgery
One of the most frequently performed procedures in maxillofacial surgery is impacted wisdom tooth surgery. An impacted tooth is defined as a tooth that is not fully or partially erupted and is blocked from eruption by another tooth, bone, or soft tissue, and thus has a low probability of eruption. The tooth is blocked from eruption by adjacent hard or soft tissue, including bone or dense soft tissue. The most common complications after impacted wisdom tooth surgery are pain, edema, trismus, and alveolar osteitis.
| Study group | Role | What they receive |
|---|---|---|
| Tissue adhesive (Periacryl 90) | Active comparator | After the extraction of the impacted lower wisdom tooth, the wound area was closed using tissue adhesive. Receives: Procedure: Impacted lower wisdom tooth extraction |
| Silk suture | Active comparator | After the extraction of the impacted lower wisdom tooth, the wound area was closed using silk sutures. Receives: Procedure: Impacted lower wisdom tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Healing
All patients were called for follow-up visits on the 3rd day and 1 week later and were examined by the same physician. During the follow-up visits, the status of wound healing was evaluated in 3 different statuses. These 3 statuses were recorded as good, acceptable and poor. Wound healing deteriorated from good to poor.
Measured: 3. and 7. days
Edema
In order to evaluate edema, the distances between points marked extra orally in 5 different regions on the face were measured and recorded in mm (angulus-tragus point, angulus-lateral corner of the eye, angulus-nasal wing, angulus-lateral commissure, angulus-pogonion point).
Measured: 3. and 7. days
Trismus
The evaluation of trismus was evaluated by measuring the mouth opening before the operation and also on the 3rd and 7th days after the operation. The patients were asked to open their mouths as much as possible and the distance between the incisal edges of the lower and upper central incisors was measured in millimeters with the help of a precision ruler. This process was repeated 3 times for each measurement and the arithmetic average of the values found was taken.
Measured: 3. and 7. days
VAS Pain Scor
VAS (Visual Analog Scale) was used for pain assessment. VAS pain assessment includes scores between 0 and 10. (0: no pain; 10: unbearable pain.) As the score increases, the pain worsens.
Measured: 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start1 May 2022
- Primary completion30 Apr 2023
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Impacted Mandibular Third Molar ExtractionStudies 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
- None (open label)
- 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
- NCT06811974
- Sponsor's protocol ID
- YYU-04/18.05.2022
- Status last verified
- Feb 2025
- First submitted
- 24 Jan 2025
- Last updated
- 10 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bao Z, Gao M, Sun Y, Nian R, Xian M. The recent progress of tissue adhesives in design strategies, adhesive mechanism and applications. Mater Sci Eng C Mater Biol Appl. 2020 Jun;111:110796. doi: 10.1016/j.msec.2020.110796. Epub 2020 Mar 5.
PubMed 32279807Bamgbose BO, Akinwande JA, Adeyemo WL, Ladeinde AL, Arotiba GT, Ogunlewe MO. Effects of co-administered dexamethasone and diclofenac potassium on pain, swelling and trismus following third molar surgery. Head Face Med. 2005 Nov 7;1:11. doi: 10.1186/1746-160X-1-11.
PubMed 16274480Bal-Ozturk A, Cecen B, Avci-Adali M, Topkaya SN, Alarcin E, Yasayan G, Ethan YC, Bulkurcuoglu B, Akpek A, Avci H, Shi K, Shin SR, Hassan S. Tissue Adhesives: From Research to Clinical Translation. Nano Today. 2021 Feb;36:101049. doi: 10.1016/j.nantod.2020.101049. Epub 2020 Dec 20.
PubMed 33425002Ballestas SA, Turner TC, Kamalakar A, Stephenson YC, Willett NJ, Goudy SL, Botchwey EA. Improving hard palate wound healing using immune modulatory autotherapies. Acta Biomater. 2019 Jun;91:209-219. doi: 10.1016/j.actbio.2019.04.052. Epub 2019 Apr 25.
PubMed 31029828Asher R, Chacartchi T, Tandlich M, Shapira L, Polak D. Microbial accumulation on different suture materials following oral surgery: a randomized controlled study. Clin Oral Investig. 2019 Feb;23(2):559-565. doi: 10.1007/s00784-018-2476-0. Epub 2018 May 2.
PubMed 29717362Amiel GE, Sukhotnik I, Kawar B, Siplovich L. Use of N-butyl-2-cyanoacrylate in elective surgical incisions--longterm outcomes. J Am Coll Surg. 1999 Jul;189(1):21-5. doi: 10.1016/s1072-7515(99)00068-x.
PubMed 10401736American Academy of Pediatric Dentistry Ad Hoc Committee on Pedodontic Radiology; American Academy of Pediatric Dentistry Council on Clinical Affairs. Guideline on prescribing dental radiographs for infants, children, adolescents, and persons with special health care needs. Pediatr Dent. 2005-2006;27(7 Suppl):185-6. No abstract available.
PubMed 16541920Al-Moraissi EA, Al-Zendani EA, Al-Selwi AM. Efficacy of Submucosal Injection of Chymotrypsin, Oral Serratiopeptidase or Oral Dexamethasone in Reducing Postoperative Complications Following Impacted Lower Third Molar Surgery: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial. Front Oral Health. 2020 Dec 8;1:575176. doi: 10.3389/froh.2020.575176. eCollection 2020.
PubMed 35047980Akbulut N, Ustuner E, Atakan C, Colok G. Comparison of the effect of naproxen, etodolac and diclofenac on postoperative sequels following third molar surgery: a randomised, double-blind, crossover study. Med Oral Patol Oral Cir Bucal. 2014 Mar 1;19(2):e149-56. doi: 10.4317/medoral.19518.
PubMed 24316711Ali AS, Benton JA, Yates JM. Risk of inferior alveolar nerve injury with coronectomy vs surgical extraction of mandibular third molars-A comparison of two techniques and review of the literature. J Oral Rehabil. 2018 Mar;45(3):250-257. doi: 10.1111/joor.12589. Epub 2017 Dec 11.
PubMed 29171914
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. 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 Dental Surgery
- ClinicalTrials.gov ID
- NCT06811974
- Acronym / sponsor ID
- YYU-04/18.05.2022
- Keywords
- tissue adhesive, impacted wisdom tooth, silk suture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Yuzuncu Yil UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 6 Feb 2025 (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.
In this study, bilateral It is aimed to compare the efficacy of tissue adhesive (Periacryl 90) and silk suture in mandibular impacted wisdom tooth surgery.
Detailed description
In the study carried out on a total 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 bilateral bilateral 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 determined as the control group and the wound was closed with silk suture. The selected party was determined by the closed envelope method. After the first impacted tooth was extracted, it was waited until the wound healed and the symptoms disappeared completely, then the other tooth was extracted. In both tooth extractions, wound healing, edema and trismus were evaluated on the 3rd and 7th days. Wound healing was evaluated as good, acceptable and bad. VAS (Visual Analog Scale) was used for pain assessment and assessment was made at 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tissue adhesive (Periacryl 90) | Active comparator | Procedure: Impacted lower wisdom tooth extractionAfter the extraction of the impacted lower wisdom tooth, the wound area was closed using tissue adhesive. |
| Silk suture | Active comparator | Procedure: Impacted lower wisdom tooth extractionAfter the extraction of the impacted lower wisdom tooth, the wound area was closed using silk sutures. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy individuals aged 18-35 years who accepted the study conditions and had bilateral, bone or mucosal retention, and completely impacted wisdom teeth in the similar position with an indication for extraction due to prophylactic or orthodontic treatment in the lower jaw were included in the study.
Key exclusion criteria (8 listed)
- Individuals with any systemic disease
- Individuals with a history of allergy to the drugs to be used in the study
- Pregnant and breastfeeding individuals
- Individuals with pain, swelling or trismus in the last 10 days
- Individuals with different positions on the right and left sides
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 |
|---|---|---|
| Impacted lower wisdom tooth extractionOne of the most frequently performed procedures in maxillofacial surgery is impacted wisdom tooth surgery. An impacted tooth is defined as a tooth that is not fully or partially erupted and is blocked from eruption by another tooth, bone, or soft tissue, and thus has a low probability of eruption. The tooth is blocked from eruption by adjacent hard or soft tissue, including bone or dense soft tissue. The most common complications after impacted wisdom tooth surgery are pain, edema, trismus, and alveolar osteitis. | Procedure or surgery | Silk suture, Tissue adhesive (Periacryl 90) |
Primary outcome
Wound Healing
Time frame: 3. and 7. days
All patients were called for follow-up visits on the 3rd day and 1 week later and were examined by the same physician. During the follow-up visits, the status of wound healing was evaluated in 3 different statuses. These 3 statuses were recorded as good, acceptable and poor. Wound healing deteriorated from good to poor.
Edema
Time frame: 3. and 7. days
In order to evaluate edema, the distances between points marked extra orally in 5 different regions on the face were measured and recorded in mm (angulus-tragus point, angulus-lateral corner of the eye, angulus-nasal wing, angulus-lateral commissure, angulus-pogonion point).
Trismus
Time frame: 3. and 7. days
The evaluation of trismus was evaluated by measuring the mouth opening before the operation and also on the 3rd and 7th days after the operation. The patients were asked to open their mouths as much as possible and the distance between the incisal edges of the lower and upper central incisors was measured in millimeters with the help of a precision ruler. This process was repeated 3 times for each measurement and the arithmetic average of the values found was taken.
VAS Pain Scor
Time frame: 3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.
VAS (Visual Analog Scale) was used for pain assessment. VAS pain assessment includes scores between 0 and 10. (0: no pain; 10: unbearable pain.) As the score increases, the pain worsens.
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 10 Feb 2025.
- Background: PubMed 32279807Bao Z, Gao M, Sun Y, Nian R, Xian M. The recent progress of tissue adhesives in design strategies, adhesive mechanism and applications. Mater Sci Eng C Mater Biol Appl. 2020 Jun;111:110796. doi: 10.1016/j.msec.2020.110796. Epub 2020 Mar 5.
- Background: PubMed 16274480Bamgbose BO, Akinwande JA, Adeyemo WL, Ladeinde AL, Arotiba GT, Ogunlewe MO. Effects of co-administered dexamethasone and diclofenac potassium on pain, swelling and trismus following third molar surgery. Head Face Med. 2005 Nov 7;1:11. doi: 10.1186/1746-160X-1-11.
- Background: PubMed 33425002Bal-Ozturk A, Cecen B, Avci-Adali M, Topkaya SN, Alarcin E, Yasayan G, Ethan YC, Bulkurcuoglu B, Akpek A, Avci H, Shi K, Shin SR, Hassan S. Tissue Adhesives: From Research to Clinical Translation. Nano Today. 2021 Feb;36:101049. doi: 10.1016/j.nantod.2020.101049. Epub 2020 Dec 20.
- Background: PubMed 31029828Ballestas SA, Turner TC, Kamalakar A, Stephenson YC, Willett NJ, Goudy SL, Botchwey EA. Improving hard palate wound healing using immune modulatory autotherapies. Acta Biomater. 2019 Jun;91:209-219. doi: 10.1016/j.actbio.2019.04.052. Epub 2019 Apr 25.
- Background: PubMed 29717362Asher R, Chacartchi T, Tandlich M, Shapira L, Polak D. Microbial accumulation on different suture materials following oral surgery: a randomized controlled study. Clin Oral Investig. 2019 Feb;23(2):559-565. doi: 10.1007/s00784-018-2476-0. Epub 2018 May 2.
- Background: PubMed 10401736Amiel GE, Sukhotnik I, Kawar B, Siplovich L. Use of N-butyl-2-cyanoacrylate in elective surgical incisions--longterm outcomes. J Am Coll Surg. 1999 Jul;189(1):21-5. doi: 10.1016/s1072-7515(99)00068-x.
- Background: PubMed 16541920American Academy of Pediatric Dentistry Ad Hoc Committee on Pedodontic Radiology; American Academy of Pediatric Dentistry Council on Clinical Affairs. Guideline on prescribing dental radiographs for infants, children, adolescents, and persons with special health care needs. Pediatr Dent. 2005-2006;27(7 Suppl):185-6. No abstract available.
- Background: PubMed 35047980Al-Moraissi EA, Al-Zendani EA, Al-Selwi AM. Efficacy of Submucosal Injection of Chymotrypsin, Oral Serratiopeptidase or Oral Dexamethasone in Reducing Postoperative Complications Following Impacted Lower Third Molar Surgery: A Prospective, Randomized, Double-Blind, Controlled Clinical Trial. Front Oral Health. 2020 Dec 8;1:575176. doi: 10.3389/froh.2020.575176. eCollection 2020.
- Background: PubMed 24316711Akbulut N, Ustuner E, Atakan C, Colok G. Comparison of the effect of naproxen, etodolac and diclofenac on postoperative sequels following third molar surgery: a randomised, double-blind, crossover study. Med Oral Patol Oral Cir Bucal. 2014 Mar 1;19(2):e149-56. doi: 10.4317/medoral.19518.
- Background: PubMed 29171914Ali AS, Benton JA, Yates JM. Risk of inferior alveolar nerve injury with coronectomy vs surgical extraction of mandibular third molars-A comparison of two techniques and review of the literature. J Oral Rehabil. 2018 Mar;45(3):250-257. doi: 10.1111/joor.12589. Epub 2017 Dec 11.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impacted lower wisdom tooth extraction in people with Impacted Mandibular Third Molar Extraction, 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 10 Feb 2025. 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. 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?
Wound Healing (time frame: 3. and 7. 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?
On the ClinicalTrials.gov record for NCT06811974, which also lists 10 linked publications.
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 10 Feb 2025.