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

NCT06811974 | Completed

• 1 other identifier: YYU-04/18.05.2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Impacted Mandibular Third Molar Extraction

Keywords

tissue adhesive; impacted wisdom tooth; silk suture

Outcome Measures

Primary Outcomes (4)

• 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.

  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).

  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.

  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.

  3, 6, 12 and 24 hours and 2, 3, 4, 5, 6 and 7 days.

Study Arms (2)

Tissue adhesive (Periacryl 90)

ACTIVE COMPARATOR

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

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.

Procedure: Impacted lower wisdom tooth extraction

Interventions

Impacted lower wisdom tooth extraction 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; Tissue adhesive (Periacryl 90)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi

Van, 65080, Turkey (Türkiye)

Location

Related Publications (10)

• 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.

  PMID: 32279807 BACKGROUND

• 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.

  PMID: 16274480 BACKGROUND

• 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.

  PMID: 33425002 BACKGROUND

• 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.

  PMID: 31029828 BACKGROUND

• 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.

  PMID: 29717362 BACKGROUND

• 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.

  PMID: 10401736 BACKGROUND

• 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.

  PMID: 16541920 BACKGROUND

• 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.

  PMID: 35047980 BACKGROUND

• 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.

  PMID: 24316711 BACKGROUND

• 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.

  PMID: 29171914 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 24, 2025
• First Posted: February 6, 2025
• Study Start: May 1, 2022
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2024
• Last Updated: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)