The Relationship Between Sense of Coherence and Wound Healing.

NCT06635031 | Completed

• 1 other identifier: 23/77
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to investigate the relationship between sence of coherence (SOC) and surgery-related oral wound healing. The study was consisted of one hundred and sixty patients of both sexes (female,male) who were scheduled for oral surgery. Pre-operatively the patients were asked to complete a questionnaire designed to measure their Sense of Coherence (SOC). The wound healing was evaluated after 4 days, 14 days and 6 weeks after surgical operation. The results were analyzed statistically.

Conditions

Wound Heal; Sense of Coherence

Outcome Measures

Primary Outcomes (2)

• Evaluation of Sence of Coherence

  Sence of Coherence (SOC) was measured using a 13-question survey, where participants rate their answers on a scale from 1 to 7, with 1 representing "never" and 7 indicating "very often." Total scores above 45 are regarded as indicative of high SOC values.

  6 weeks

• Evaluation of Oral Wound Healing

  Wound Healing (WH) was assessed by using a scale called Inflammatory Proliferative Remodeling (IPR) Scale. According to the scale, each phase of the healing is scored based on the parameters, including edema, bleeding, swelling. The total score of the IPR scale ranges from 0 to 16; 0-4 indicates poor healing; 5-10, acceptable healing; and 11-16, excellent healing.

  6 weeks

Secondary Outcomes (1)

• Evaluation of post-operative pain

  6 weeks

Interventions

Oral surgery PROCEDURE

The patients were undergone routine oral surgeries. Surgical procedures included an incision on the oral mucosa and full-thickness flap reflection, and the primary wound closure was achieved by polyglactin absorbable sutures.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

One hundred and sixty adult patients of both sexes

You may qualify if:

• Adult patients aged between 18-65 years
• Patients classified as American Society of Anesthesiologists (ASA) physical status ASA I
• Patients scheduled to undergo oral surgery

You may not qualify if:

• Not consenting to participate
• Intake of steroid, bisphosphonate or immune-suppressive medication
• Receiving radiotherapy in the head and neck area
• Pregnancy
• Inability to self-evaluate, and inability to communicate verbally and in writing.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surgery, Oral

Intervention Hierarchy (Ancestors)

Dentistry

Study Officials

• ALANUR ÇİFTÇİ ŞİŞMAN, PhD, DDS

  Saglik Bilimleri Universitesi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 10, 2024
• Study Start: November 10, 2023
• Primary Completion: March 10, 2024
• Study Completion: May 1, 2024
• Last Updated: October 10, 2024

Record last verified: 2023-11

Locations

TU (1)