Wound HealNCT06635031
The Relationship Between Sense of Coherence and Wound Healing.
An observational study of Wound Heal and Sense of Coherence, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Heal, Sense of Coherence
- What is being tested?
- Oral surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 160 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Nov 2023to 1 May 2024
- How long will I take part?
- 6 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: One hundred and sixty adult patients of both sexes
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Conditions
- Wound Heal, Sense of Coherence
- Being tested
- Oral surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral surgeryProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Secondary outcomes (1)
Evaluation of post-operative pain
To measure pain, participants were asked to describe their pain at follow-up appointments using a Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst imaginable pain.
The numerical values obtained from these two scales were subjected to statistical analysis, to determine if there was a relationship between Sence of Coherence and post-operative pain.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start10 Nov 2023
- Primary completion10 Mar 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 6 Weeks
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- ALANUR ÇİFTÇİ ŞİŞMAN, PhD, DDS, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06635031
- Sponsor's protocol ID
- 23/77
- Status last verified
- Nov 2023
- First submitted
- 24 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ciftci Sisman A, Beker RC, Kiziltan Eliacik BB. Assessment of the relationship between sense of coherence and surgery-related oral wound healing by using a contemporary scale: a prospective cohort study. BMC Oral Health. 2025 Jul 2;25(1):988. doi: 10.1186/s12903-025-06478-1.
PubMed 40604873
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06635031
- Acronym / sponsor ID
- 23/77
- Conditions
- Wound Heal, Sense of Coherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 10 Nov 2023 (actual)
- Primary completion
- 10 Mar 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Weeks
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- One hundred and sixty adult patients of both sexes
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral surgeryThe 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. | Procedure or surgery | – |
Primary outcome
Evaluation of Sence of Coherence
Time frame: 6 weeks
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.
Evaluation of Oral Wound Healing
Time frame: 6 weeks
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.
1 secondary outcome
Evaluation of post-operative pain
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
- Derived from this study: PubMed 40604873Ciftci Sisman A, Beker RC, Kiziltan Eliacik BB. Assessment of the relationship between sense of coherence and surgery-related oral wound healing by using a contemporary scale: a prospective cohort study. BMC Oral Health. 2025 Jul 2;25(1):988. doi: 10.1186/s12903-025-06478-1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ALANUR ÇİFTÇİ ŞİŞMAN, PhD, DDS principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wound Heal and Sense of Coherence, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Sence of Coherence (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06635031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.