Donor Site ComplicationNCT04403503
The Influence of Tissue Adhesive to Palatal Donor Site Healing.
A study testing Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT] and Cyanoacrylate, Isobutyl in people with Donor Site Complication, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Donor Site Complication
- What is being tested?
- Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT] and Cyanoacrylate, Isobutyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2018to 1 Mar 2019
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ≥18;
- PPS indication that needs CTG in 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 surgical site;
- systemic disease;
- pregnancy;
- use of medications with potential adverse effects to periodontal tissues
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial
CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. The data of pain perception (PP) will be measured using visual analog scale, quantity of analgesics (QA), secondary bleeding (SB), epithelization level (EL), and color match (CM) will be assessed prospectively. these outcomes will be evaluated in the first 7 days and 14th, 21th, and 28th days. Patient reported outcomes will be recorded using OHIB 14 questionnaire.
- Conditions
- Donor Site Complication
- Being tested
- Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT], Cyanoacrylate, Isobutyl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]Drug
Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)
Cyanoacrylate, IsobutylDrug
Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).
| Study group | Role | What they receive |
|---|---|---|
| Gelatine Sponge | Active comparator | After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) Receives: Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT] |
| Gelatine sponge +Cyanoacrylate | Active comparator | After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group) Receives: Drug: Cyanoacrylate, Isobutyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor site pain perception (PP)
Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain)
Measured: first week
Secondary outcomes (10)
Primary bleeding time (PBT)
Immediately after harvesting, sterile gauze was compressed to the palatal wound for 2 minutes, blood wiped once in every 30 seconds until bleeding stops. The duration was recorded as primary bleeding time (PBT).
Measured: during surgery
Graft height (GH)
Dimensions were measured with periodontal probe
Measured: during surgery
Graft width (GW)
Dimensions were measured with periodontal probe
Measured: during surgery
Graft thickness (GT)
Dimensions were measured with periodontal probe
Measured: during surgery
Working time (WT)
Harvesting process was recorded
Measured: during surgery
Quantity of analgesics (QA)
Patients recorded the quantity of analgesics (QA) taken
Measured: first week
Secondary bleeding (SB)
Patients recorded presence/absence of secondary bleeding (SB) (yes or no).
Measured: first week
Sensation loss (SL)
Sensation loss (SL) was scored as none, medium or severe
Measured: first week, second week , third week, fourth week.
Color match (CM)
Color match (CM) with the adjacent tissue was determined by using a VAS scale (0: absence of harmony, 10: excellent harmony)
Measured: first week, second week, third week, fourth week.
Epithelization level (EL)
Epithelization level (EL) was scored as none, partial or full epithelization by means of bubble formation after dripping hydrogen peroxide (3%) to the wound surface following surgery
Measured: first week, second week, third week, fourth week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start1 Jul 2018
- Primary completion1 Feb 2019
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Donor Site ComplicationStudies of the same condition, open and under way.
- More trials run by Hacettepe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 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
- NCT04403503
- Sponsor's protocol ID
- Cyanoacrylate
- Status last verified
- Oct 2024
- First submitted
- 21 May 2020
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Tissue Adhesive to Palatal Donor Site Healing. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04403503
- Acronym / sponsor ID
- Cyanoacrylate
- Conditions
- Donor Site Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 27 May 2020 (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.
CTG was harvested from 21 patients in each group. Donor site was treated with either GS (control) or GS+CY (test). Palatal tissue thickness, graft dimensions, working time (WT) and primary bleeding time were recorded intraoperatively. The data of pain perception (PP) will be measured using visual analog scale, quantity of analgesics (QA), secondary bleeding (SB), epithelization level (EL), and color match (CM) will be assessed prospectively. these outcomes will be evaluated in the first 7 days and 14th, 21th, and 28th days. Patient reported outcomes will be recorded using OHIB 14 questionnaire.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gelatine Sponge | Active comparator | Drug: Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]After local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) |
| Gelatine sponge +Cyanoacrylate | Active comparator | Drug: Cyanoacrylate, IsobutylAfter local anesthesia (2% articaine HCl with epinephrine 1:100,000) administration, palatal thickness was measured by perpendicularly inserting a Michigan-O periodontal probe from the corners of the rectangular donor area and mean value was recorded as 'palatal tissue thickness (PTT)'. Epithelialized gingival graft was harvested with the method described by Zucchelli et al.19 After a rectangular shaped initial incision, graft with 1-1.5 mm thickness was harvested approximately 1.5 to 3 mm away from gingival margins of upper teeth. After harvesting, excess fatty tissues were removed and de-epithelialization was performed to obtain DGG. Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- age ≥18;
- PPS indication that needs CTG in 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 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;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) | Drug | Gelatine Sponge |
| Cyanoacrylate, IsobutylDonor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group). | Drug | Gelatine sponge +Cyanoacrylate |
Primary outcome
Donor site pain perception (PP)
Time frame: first week
Patients score their daily donor site pain perception (PP) level by giving numbers from 0 to 10 according to the visual analog scale (VAS) (0: no pain, 1: minimal pain, 10: severe pain)
10 secondary outcomes
Primary bleeding time (PBT)
Time frame: during surgery
Graft height (GH)
Time frame: during surgery
Graft width (GW)
Time frame: during surgery
Graft thickness (GT)
Time frame: during surgery
Working time (WT)
Time frame: during surgery
Quantity of analgesics (QA)
Time frame: first week
Secondary bleeding (SB)
Time frame: first week
Sensation loss (SL)
Time frame: first week, second week , third week, fourth week.
Color match (CM)
Time frame: first week, second week, third week, fourth week.
Epithelization level (EL)
Time frame: first week, second week, third week, fourth 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 2 Oct 2024.
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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;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT] and Cyanoacrylate, Isobutyl in people with Donor Site Complication, 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 2 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?
Donor site pain perception (PP) (time frame: first week). 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 2 Oct 2024.