NCT06020157

Brief Summary

The study aims to compare two different suture techniques regarding wound healing. In this research, which is designed as a prospective study, a comparison of simple and locked continuous suture techniques will be done. For this purpose, Selçuk University Faculty of Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap opened (for alveoplasty). Half of the arch will be closed by a simple suture. The other half will be closed by continuous suture technique. It is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day when the sutures will be removed. On the 7th day, it is planned to evaluate the suture removal pain for the patient and the ease of suture removal for the operator with the VAS scale. Data collected from these assessments will be statistically compared for simple and continuous sutures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2023

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

First Submitted

Initial submission to the registry

August 25, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

October 5, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

August 25, 2023

Last Update Submit

February 27, 2024

Conditions

Outcome Measures

Primary Outcomes (6)

  • Early Wound Healing Score-1

    Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)

    Day 1

  • Early Wound Healing Score-3

    Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)

    Day 3

  • Early Wound Healing Score-7

    Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)

    Day 7

  • Suturing Time

    The time between start and end of suture

    1 minutes after ending suture

  • Pain at Suture Removal

    VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.

    Day 7

  • Suture Removal Difficulty

    VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.

    Day 7

Study Arms (2)

Simple Suture Group

EXPERIMENTAL
Other: Simple Suture Technique

Continuous Suture Group

EXPERIMENTAL
Other: Continuous Suture Technique

Interventions

The half of the full arch flap will be closed by the simple suture technique.

Simple Suture Group

The half of the full arch flap will be closed by the continuous suture technique.

Continuous Suture Group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Needing full arch alveoplasty
  • No smoking

You may not qualify if:

  • Uncontrolled systemic condition
  • Not participating in control appointments
  • Complications about wound healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University, Dentistry Faculty

Konya, Selçuklu, Turkey (Türkiye)

Location

Study Officials

  • Şeyma Koyuncu

    Selcuk University, Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 25, 2023

First Posted

August 31, 2023

Study Start

October 5, 2023

Primary Completion

February 27, 2024

Study Completion

February 27, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Locations