Wound HealNCT06083259
Cyanoacrylate With or Without Suture?
A study testing Gelatin sponge stabilization with suture and cyanoacrylate and Gelatin sponge stabilization with cyanoacrylate in people with Wound Heal, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. 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?
- Gelatin sponge stabilization with suture and cyanoacrylate and Gelatin sponge stabilization with cyanoacrylate
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Dec 2023to 16 Aug 2024
- 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
- age ≥18;
- mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible;
- stable periodontium after phase I therapy;
- full-mouth plaque and bleeding scores <15%
Who cannot join
- previous palatal harvesting history;
- unstable endodontic conditions;
- tooth mobility at the surgical site;
- systemic disease;
- pregnancy;
- use of medications with potential adverse effects on periodontal tissues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Cyanoacrylate Require Supportive Suturing to Reduce Seconder Bleeding and Stabilizing Biomaterial at the Donor Site?
An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.
- Conditions
- Wound Heal
- Being tested
- Gelatin sponge stabilization with suture and cyanoacrylate, Gelatin sponge stabilization with cyanoacrylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin sponge stabilization with suture and cyanoacrylateDevice
The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group)
Gelatin sponge stabilization with cyanoacrylateProcedure or surgery
Seconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group)
| Study group | Role | What they receive |
|---|---|---|
| gelatin sponge + cyanoacrylate + suspending sutures | Active comparator | After administration of local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000), palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area. Epithelialized gingival graft will be harvested. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge + cyanoacrylate + suspending sutures. Receives: Device: Gelatin sponge stabilization with suture and cyanoacrylate |
| gelatin sponge + cyanoacrylate | Active comparator | After local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000) administration, palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and the mean value will be recorded as palatal tissue thickness. The epithelialized gingival graft will be harvested using 15 knives. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge and cyanoacrylate without sutures. Receives: Procedure: Gelatin sponge stabilization with cyanoacrylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor site pain perception
Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain)
Measured: everyday in first week
Secondary bleeding time
Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).
Measured: during first week
Secondary outcomes (9)
Graft height
Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)
Measured: during surgery
Graft width
Dimensions will be measured during surgery by clinician using Michigan O probe.(will be reported in mm)
Measured: during surgery
Graft thickness
Dimensions will be measured during surgery by clinician using Michigan O probe (will be reported in mm)
Measured: during surgery
Working time
Harvesting process will be recorded by an blinded research assistant
Measured: during surgery
Quantity of analgesics
Patients recorded the quantity of analgesics taken will be reported as quantity of pill
Measured: first week
Sensation loss
Sensation loss will be scored by the help of clinician comparing with the symmetrical side an will be recorded as no-loss, medium loss or severe loss
Measured: first week, second week , third week, fourth week.
Color match
Color match with the adjacent tissue was determined by researcher using a Visual Analog Pain Scale scale (0: absence of harmony, 10: excellent harmony)
Measured: first week, second week, third week, fourth week.
Epithelization level
Epithelization level was scored by researcher as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface.
Measured: first week, second week, third week, fourth week.
The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.
The questionnaire has 14 items with answers rated on a 5-point Likert scale (from 1 = never to 5 = very often) to indicate a level of different problems related to oral health
Measured: first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start5 Dec 2023
- Primary completion16 Aug 2024
- Study completion16 Aug 2024
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.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gencay Keceli, Hacettepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06083259
- Sponsor's protocol ID
- Palatal Wound Healing
- Status last verified
- Aug 2024
- First submitted
- 21 Sep 2023
- Last updated
- 19 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cyanoacrylate Require Supportive Suturing to Reduce Seconder Bleeding and Stabilizing Biomaterial at the Donor Site?
- ClinicalTrials.gov ID
- NCT06083259
- Acronym / sponsor ID
- Palatal Wound Healing
- Conditions
- Wound Heal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 5 Dec 2023 (actual)
- Primary completion
- 16 Aug 2024 (actual)
- Study completion
- 16 Aug 2024 (actual)
- First posted
- 13 Oct 2023 (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.
An epithelialized gingival graft will be harvested from the palate for the treatment of various mucogingival deformities. The donor site will be treated with either a combination of a collagen sponge and cyanoacrylate or a collagen sponge, cyanoacrylate, and suspending sutures. Intraoperatively, measurements will be taken for palatal tissue thickness, graft dimensions, working time, and primary bleeding time. Data regarding pain perception will be gauged using a visual analog scale, and the number of analgesics, secondary bleeding, epithelization level, and color match will be assessed prospectively. These outcomes will be evaluated on the first 7 days and subsequently on the 14th, 21st, and 28th days. Patient-reported outcomes will be recorded using the Oral Health Impact Profile-14 questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gelatin sponge + cyanoacrylate + suspending sutures | Active comparator | Device: Gelatin sponge stabilization with suture and cyanoacrylateAfter administration of local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000), palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area. Epithelialized gingival graft will be harvested. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge + cyanoacrylate + suspending sutures. |
| gelatin sponge + cyanoacrylate | Active comparator | Procedure: Gelatin sponge stabilization with cyanoacrylateAfter local anesthesia (2% articaine hydrochloride with epinephrine 1:100,000) administration, palatal thickness will be measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and the mean value will be recorded as palatal tissue thickness. The epithelialized gingival graft will be harvested using 15 knives. After a rectangular-shaped initial incision, a graft with 1-1.5 mm thickness will be harvested approximately 1.5 to 3 mm away from the gingival margins of the upper teeth. The donor site will be closed with a gelatin sponge and cyanoacrylate without sutures. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥18;
- mucogingival surgical treatment indication that needs connective tissue graft in the anterior mandible;
- stable periodontium after phase I therapy;
- full-mouth plaque and bleeding scores <15%
Key exclusion criteria (6 listed)
- previous palatal harvesting history;
- unstable endodontic conditions;
- tooth mobility at the surgical site;
- systemic disease;
- pregnancy;
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 |
|---|---|---|
| Gelatin sponge stabilization with suture and cyanoacrylateThe donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, Ethicon, USA)+ supporting sutures (control group) | Device | gelatin sponge + cyanoacrylate + suspending sutures |
| Gelatin sponge stabilization with cyanoacrylateSeconder The donor site will be closed both with gelatin sponge +Cyanoacrylate (Spongostan®, USA) (test group) | Procedure or surgery | gelatin sponge + cyanoacrylate |
Primary outcome
Donor site pain perception
Time frame: everyday in first week
Patients score their daily donor site pain perception using visual analog score level by giving numbers from 0 to 10 according to the visual analog scale (0: no pain, 1: minimal pain, 10: severe pain)
Secondary bleeding time
Time frame: during first week
Patients will record presence or absence of secondary bleeding (presence=1 or absence=0).
9 secondary outcomes
Graft height
Time frame: during surgery
Graft width
Time frame: during surgery
Graft thickness
Time frame: during surgery
Working time
Time frame: during surgery
Quantity of analgesics
Time frame: first week
Sensation loss
Time frame: first week, second week , third week, fourth week.
Color match
Time frame: first week, second week, third week, fourth week.
Epithelization level
Time frame: first week, second week, third week, fourth week.
The Oral Health Impact Profile-14 is a questionnaire that measures how oral disorders impact a patient's quality of life.
Time frame: first week
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 19 Aug 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gelatin sponge stabilization with suture and cyanoacrylate and Gelatin sponge stabilization with cyanoacrylate in people with Wound Heal, run by Hacettepe 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 4 inclusion and 6 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 19 Aug 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?
Donor site pain perception (time frame: everyday in first week). 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?
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 19 Aug 2024.