Clinical trial NCT06635031: The Relationship Between Sense of Coherence and Wound Healing.
Official title: Assessment of the Relationship Between Sense of Coherence and the Healing of Surgery-related Intraoral Wound by Using a Novel Scale: A Clinical Randomized Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wound Heal
Sense of Coherence
Lead sponsor: Saglik Bilimleri Universitesi
Sponsor class: OTHER
First posted: 2024-10-10
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and sixty adult patients of both sexes

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.

Detailed description: Many factors play a role in wound healing (WH) including physiologic factors. The concept of Sense of Coherence (SOC), reflects an individual's capacity to respond to stressful situations. High SOC scores indicate a strong SOC, and individuals with strong SOC are reported to tolerate stress better. Additionally, a strong SOC has been associated with fewer symptoms and significantly fewer issues related to oral condition. The aim of this study is to evaluate the relationship between SOC and wound healing following oral surgery. The study included 160 patients of both sexes (female,male). An informed consent form was obtained from all participants. Pre-operatively the patients were asked to complete a questionnaire designed to measure their Sense of Coherence (SOC). A blinded operator, who was not involved in the operation, recorded all data of the patients pre-operatively. All patients were undergone oral surgery. All surgical procedures were performed by the second maxillofacial surgeon. The first blinded operatoand conducted postoperative measurements. The wound healing was evaluated after 4 days, 14 days and 6 weeks after surgical operation. To evaluate of wound healing, a scale named Inflammatory Proliferative Remodeling (IPR) Scale was used. According to this scale, patients were recalled 3 days, 14 days and 6 weeks after surgical operation. The third blinded researcher was responsible for the analysis data.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Evaluation of Sence of Coherence
timeFrame: 6 weeks
measure: Evaluation of Oral Wound Healing
timeFrame: 6 weeks
Secondary outcomes:
measure: Evaluation of post-operative pain
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: ALANUR ÇİFTÇİ ŞİŞMAN, PhD, DDS
role: PRINCIPAL_INVESTIGATOR
References: