NCT07735598

Brief Summary

Summary: This study compares two methods used to close the gum after the surgical removal of impacted lower wisdom teeth: a medical tissue adhesive and traditional silk sutures. Both closure techniques are evaluated for postoperative pain, bleeding, healing, and the local inflammatory response.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 10, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2026

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

July 20, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2026

Completed
Last Updated

July 30, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 20, 2026

Last Update Submit

July 27, 2026

Conditions

Mandibular Third Molar/Surgery

Keywords

Mandibular Third MolarTissue AdhesivesWound Healing

Outcome Measures

Primary Outcomes (2)

  • Postoperative bleeding

    Evaluation of the intensity of postoperative bleeding during the first three days after surgery using a Numerical Rating Scale (NRS) ranging from 0 to 3, where higher scores indicate more severe (clinically worse) bleeding.

    7 days

  • Postoperative pain

    Assessment of postoperative pain intensity during the first five days after surgery using a Numerical Rating Scale (NRS) ranging from 0 to 3, where higher scores indicate more severe (clinically worse) pain.

    7 days

Secondary Outcomes (2)

  • Analgesic consumption

    7 days

  • Concentrations of inflammatory cytokines as indicators of the local immunological response

    7 days

Study Arms (2)

silk suture

ACTIVE COMPARATOR

silk suture after mandibular third molar extraction

Procedure: mandibular third molar extraction - silk suture

surgical glue

EXPERIMENTAL

surgical glue after mandibular third molar extraction

Procedure: mandibular third molar extraction - surgical glue

Interventions

mandibular third molar extraction - surgical gluePROCEDURE

The experimental intervention consists of primary flap closure using n-hexyl-cyanoacrylate tissue adhesive (Ifabond® Glue) following surgical extraction of impacted mandibular third molars. The adhesive is applied directly along the wound margins under dry conditions, without the use of sutures, allowing polymerization to achieve wound approximation.

surgical glue
mandibular third molar extraction - silk suturePROCEDURE

The control intervention consists of primary flap closure using three interrupted 3/0 silk sutures following surgical extraction of impacted mandibular third molars. After repositioning the mucoperiosteal flap, interrupted sutures are placed to achieve primary wound closure according to standard surgical practice.

silk suture

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older.
  • Healthy individuals (ASA I or II) with no history of uncontrolled systemic disease.
  • Presence of bilateral partially or completely impacted mandibular third molars requiring surgical extraction.
  • Comparable clinical and radiographic characteristics of both mandibular third molars.
  • Ability and willingness to provide written informed consent.
  • Willingness and ability to comply with the study protocol and attend all scheduled follow-up visits.

You may not qualify if:

  • Age younger than 18 years.
  • Absence of bilateral impacted mandibular third molars requiring surgical extraction.
  • Pregnancy or breastfeeding.
  • Current smoking.
  • Uncontrolled systemic diseases or medical conditions affecting wound healing or bone metabolism.
  • Oncological or hematological disorders.
  • Inability or unwillingness to provide informed consent or comply with the study protocol and follow-up schedule.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CIR Dental School

Torino, 10133, Italy

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 30, 2026

Study Start

January 10, 2026

Primary Completion

June 10, 2026

Study Completion

July 10, 2026

Last Updated

July 30, 2026

Record last verified: 2026-07

Locations

IT(1)