Comparison of the Efficiency of Tissue Adhesive (Periacryl 90) and Silk Suture in Mandibular Impacted Wisdom Surgery

NCT ID: NCT06811974

Last Updated: 2025-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-01

Study Completion Date

2024-04-30

Brief Summary

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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

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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.

Conditions

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Impacted Mandibular Third Molar Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tissue adhesive (Periacryl 90)

After the extraction of the impacted lower wisdom tooth, the wound area was closed using tissue adhesive.

Group Type ACTIVE_COMPARATOR

Impacted lower wisdom tooth extraction

Intervention Type PROCEDURE

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.

Silk suture

After the extraction of the impacted lower wisdom tooth, the wound area was closed using silk sutures.

Group Type ACTIVE_COMPARATOR

Impacted lower wisdom tooth extraction

Intervention Type PROCEDURE

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.

Interventions

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Impacted lower wisdom tooth extraction

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yuzuncu Yıl University

OTHER

Sponsor Role lead

Responsible Party

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Serap Keskin Tunc

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 32279807 (View on PubMed)

Bamgbose 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.

Reference Type BACKGROUND
PMID: 16274480 (View on PubMed)

Bal-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.

Reference Type BACKGROUND
PMID: 33425002 (View on PubMed)

Ballestas 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.

Reference Type BACKGROUND
PMID: 31029828 (View on PubMed)

Asher 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.

Reference Type BACKGROUND
PMID: 29717362 (View on PubMed)

Amiel 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.

Reference Type BACKGROUND
PMID: 10401736 (View on PubMed)

American 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.

Reference Type BACKGROUND
PMID: 16541920 (View on PubMed)

Al-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.

Reference Type BACKGROUND
PMID: 35047980 (View on PubMed)

Akbulut 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.

Reference Type BACKGROUND
PMID: 24316711 (View on PubMed)

Ali 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.

Reference Type BACKGROUND
PMID: 29171914 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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YYU-04/18.05.2022

Identifier Type: -

Identifier Source: org_study_id

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