Wound HealNCT03665272
The Evaluation of the Deepithelialized Gingival Graft Healing
A study testing deepithelialized gingival graft fixation in people with Wound Heal, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to determine for blood perfusion changes. 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
- What is being tested?
- deepithelialized gingival graft fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2018to 3 Sep 2018
- Phase
- Interventional
- 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
Who may be able to join
- 18 to 65 years of age
- systemically healthy
- inadequate amount or absence of keratinized gingiva on the labial side of the lower incisor region
- no restorations on the lower incisor region
- no mucogingival surgical history in the lower incisor region
- no periodontal treatment within the previous year
Show all 9Show fewer
- no systemic antibiotics taken for 6 months before the study
- not pregnant or lactating
- no-smoking
Who cannot join
- lower 18 and upper than 65 years of age
- systemical disease
- adequate amount of keratinized gingiva on the labial side of the lower incisor region
- restorations on the lower incisor region
- mucogingival surgical history in the lower incisor region
- periodontal treatment within the previous year
Show all 9Show fewer
- systemic antibiotics taken for ‡6months before the study
- pregnancy or lactating
- smoking history or current smokers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Different Fixation Methods on Wound Healing After Deepithelialized Gingival Graft
The aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to determine for blood perfusion changes. 40 patients were devided into two groups randomly and deepithelialized gingival graft procedure was performed and healings were evaluated by laser doppler flowmetry.
Read the detailed description
This study evaluates the effects of different fixation methods on the early healing period of deepithelialized gingival grafts placed for non-root coverage gingival augmentation by laser Doppler flowmetry Forty patients were assigned to study groups: 1)test : tissue adhesive or 2) control group: suture. Forty patients completed the study. Blood perfusion in the recipient site was measured by laser doppler flowmetry on the day of surgery and at 3 and 7 days after surgery. Quality of life and pain at recipient sites were also investigated.
- Conditions
- Wound Heal
- Being tested
- deepithelialized gingival graft fixation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deepithelialized gingival graft fixationProcedure or surgery
one group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive.
| Study group | Role | What they receive |
|---|---|---|
| fixation by tissue adhesive | Experimental | In this group, deepithelialized gingival grafts were fixed by tissue adhesive without any suture. Receives: Procedure: deepithelialized gingival graft fixation |
| fixation by sutures | Experimental | In this groups, deepithelialized gingival grafts were fixed by 4.0 round vicryl sutures. Receives: Procedure: deepithelialized gingival graft fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
deepithelialized gingival graft blood perfusion change
Blood perfusions (units) were measured by laser doppler flowmetry
Measured: measurements were performed at the day of surgery, 1, 3 and 7 days.
Secondary outcomes (1)
Deepithelialized gingival graft recipient bed pain changes
In this evaluations, we did not evaluate the total range we used subscale pain evaluation by visual analog scale. visual analog scale consisted of 10 units,in combination with a graphic rating scale.On the visual analog scale,the left and right end of the graphic represented the absence of pain (minimum 0)(score 0) and the most severe pain (maximum 10) (score 10),respectively. Patients were warned to complete the visual analog scale taking into consideration the intensity of their pain in the previous 24 hours on all recall days
Measured: measurements were performed at 1, 3 and 7 days post surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start10 Jan 2018
- Primary completion3 Sep 2018
- Study completion3 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zekeriya Tasdemir, TC Erciyes University
- Investigators
- zekeriya taşdemir, phd, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03665272
- Sponsor's protocol ID
- Zeck
- Status last verified
- Sep 2018
- First submitted
- 5 Sep 2018
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Different Fixation Methods on Wound Healing After Deepithelialized Gingival Graft
- ClinicalTrials.gov ID
- NCT03665272
- Acronym / sponsor ID
- Zeck
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 3 Sep 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 11 Sep 2018 (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 aim of this study was to compare of the effects of different fixation methods on deepithelialized gingival graft wound healing. Laser doppler flowmetry method was used to determine for blood perfusion changes. 40 patients were devided into two groups randomly and deepithelialized gingival graft procedure was performed and healings were evaluated by laser doppler flowmetry.
Detailed description
This study evaluates the effects of different fixation methods on the early healing period of deepithelialized gingival grafts placed for non-root coverage gingival augmentation by laser Doppler flowmetry Forty patients were assigned to study groups: 1)test : tissue adhesive or 2) control group: suture. Forty patients completed the study. Blood perfusion in the recipient site was measured by laser doppler flowmetry on the day of surgery and at 3 and 7 days after surgery. Quality of life and pain at recipient sites were also investigated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fixation by tissue adhesive | Experimental | Procedure: deepithelialized gingival graft fixationIn this group, deepithelialized gingival grafts were fixed by tissue adhesive without any suture. |
| fixation by sutures | Experimental | Procedure: deepithelialized gingival graft fixationIn this groups, deepithelialized gingival grafts were fixed by 4.0 round vicryl sutures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 to 65 years of age
- systemically healthy
- inadequate amount or absence of keratinized gingiva on the labial side of the lower incisor region
- no restorations on the lower incisor region
- no mucogingival surgical history in the lower incisor region
Key exclusion criteria (9 listed)
- lower 18 and upper than 65 years of age
- systemical disease
- adequate amount of keratinized gingiva on the labial side of the lower incisor region
- restorations on the lower incisor region
- mucogingival surgical history in the lower incisor region
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 |
|---|---|---|
| deepithelialized gingival graft fixationone group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive. | Procedure or surgery | fixation by sutures, fixation by tissue adhesive |
Primary outcome
deepithelialized gingival graft blood perfusion change
Time frame: measurements were performed at the day of surgery, 1, 3 and 7 days.
Blood perfusions (units) were measured by laser doppler flowmetry
1 secondary outcome
Deepithelialized gingival graft recipient bed pain changes
Time frame: measurements were performed at 1, 3 and 7 days post surgery.
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 11 Sep 2018.
- Individual participant dataSharing planned: Undecided
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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.
zekeriya taşdemir, phd principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deepithelialized gingival graft fixation in people with Wound Heal, run by TC Erciyes University 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 9 inclusion and 9 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 11 Sep 2018. 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?
deepithelialized gingival graft blood perfusion change (time frame: measurements were performed at the day of surgery, 1, 3 and 7 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2018.