HealthyEarly Phase 1NCT02659904
The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
A Early Phase 1 study testing Less than 2 mm remaining palatal tissue thickness and 2 mm or more remaining palatal tissue thickness in people with Healthy and Gingival Recession, run by İlker KESKINER.
Trial summary
Our primary objective in this clinical intervention study, therefore, was to explored the effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6 months after free gingival graft harvesting in order to determine as soon as possible to re-harvest gingival graft from same site. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Healthy, Gingival Recession
- What is being tested?
- Less than 2 mm remaining palatal tissue thickness and 2 mm or more remaining palatal tissue thickness
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2016
- Phase
- Early Phase 1
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- All individuals received oral hygiene instructions and full-mouth scaling was performed. -They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra-soft toothbrush
- Individuals were re-evaluated at 8 weeks after initial therapy, and only full mounth plaque score and full mounth bleeding score <15% were enrolled to the surgical procedure
- mucogingival defects which for soft tissue graft application were indicated
- For Less than 2 mm group, between 2.5 and 3.4 mm palatal thickness at each measurement points before graft harvesting
- For 2 mm or more group, between 3.5 and 4.4 mm palatal thickness at each measurement points before graft harvesting.
Who cannot join
- periapical or palatal pathologies,
- absence teeth from canine to first molar,
- excessive forces including mechanical forces from orthodontics and occlusion,
- systemic diseases that would contraindicate for periodontal surgery or interfere with tissue healing, chronic high-dose steroid therapy, radiation or immunosuppressive therapy, pregnancy, lactation, smoking, or allergy or sensitivity to any drug
- Study participants had no history of drug therapy known to interfere with healing and to cause gingival enlargement
- Individuals who had complication such as bleeding, necrosis and delay healing during or after surgery were excluded from the study.
About this study
Our primary objective in this clinical intervention study, therefore, was to explored the effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6 months after free gingival graft harvesting in order to determine as soon as possible to re-harvest gingival graft from same site.
Read the detailed description
Forty individuals (19 males and 21 females; age range: 18-35 years) were enrolled in the study. Based on the remaining tissue at donor site after free gingival graft harvesting, individuals were divided into two groups: 1.0-1.9 millimeter (mm) remaining tissue at donor site after harvesting (n = 20), 2-2.9 mm remaining tissue at donor site after harvesting. Tissue filling in defect area from three points (mesial, central and distal) was measured at various time-points (baseline, post-operative 1, 3, 6 months).
- Conditions
- Healthy, Gingival Recession
- Being tested
- Less than 2 mm remaining palatal tissue thickness, 2 mm or more remaining palatal tissue thickness
- Keywords
- Free gingival graft, Palatal donor site healing
- Medical subject headings
- Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Less than 2 mm remaining palatal tissue thicknessOther
The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.
2 mm or more remaining palatal tissue thicknessOther
The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.
| Study group | Role | What they receive |
|---|---|---|
| Less than 2 mm | Active comparator | Palatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: Less than 2 mm remaining palatal tissue thickness Receives: Other: Less than 2 mm remaining palatal tissue thickness |
| 2 mm or more | Active comparator | Palatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: 2 mm or more remaining palatal tissue thickness Receives: Other: 2 mm or more remaining palatal tissue thickness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in remaining palatal tissue thickness
Measured: From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2015
- Study completionJan 2016
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 HealthyStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- İlker KESKINER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, İlker KESKINER, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02659904
- Sponsor's protocol ID
- 2015/103
- Status last verified
- Jan 2016
- First submitted
- 14 Jan 2016
- Last updated
- 21 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.
PubMed 27330024
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Quantitative Changes in Palatal Donor Sites Thickness After Free Gingival Graft Harvesting
- ClinicalTrials.gov ID
- NCT02659904
- Acronym / sponsor ID
- 2015/103
- Conditions
- Healthy, Gingival Recession
- Keywords
- Free gingival graft, Palatal donor site healing
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- İlker KESKINERUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 21 Jan 2016 (estimated)
- 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.
Our primary objective in this clinical intervention study, therefore, was to explored the effect of residual tissue thickness on the palatal mucosa healing from baseline to 1, 3 and 6 months after free gingival graft harvesting in order to determine as soon as possible to re-harvest gingival graft from same site.
Detailed description
Forty individuals (19 males and 21 females; age range: 18-35 years) were enrolled in the study. Based on the remaining tissue at donor site after free gingival graft harvesting, individuals were divided into two groups: 1.0-1.9 millimeter (mm) remaining tissue at donor site after harvesting (n = 20), 2-2.9 mm remaining tissue at donor site after harvesting. Tissue filling in defect area from three points (mesial, central and distal) was measured at various time-points (baseline, post-operative 1, 3, 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Less than 2 mm | Active comparator | Other: Less than 2 mm remaining palatal tissue thicknessPalatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: Less than 2 mm remaining palatal tissue thickness |
| 2 mm or more | Active comparator | Other: 2 mm or more remaining palatal tissue thicknessPalatal mucosa thickness was measured from baseline to 1, 3 and 6 months after graft harvesting Intervention: 2 mm or more remaining palatal tissue thickness |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- All individuals received oral hygiene instructions and full-mouth scaling was performed. -They were instructed to perform a non-traumatic brushing technique (Roll) using an ultra-soft toothbrush
- Individuals were re-evaluated at 8 weeks after initial therapy, and only full mounth plaque score and full mounth bleeding score <15% were enrolled to the surgical procedure
- mucogingival defects which for soft tissue graft application were indicated
- For Less than 2 mm group, between 2.5 and 3.4 mm palatal thickness at each measurement points before graft harvesting
- For 2 mm or more group, between 3.5 and 4.4 mm palatal thickness at each measurement points before graft harvesting.
Key exclusion criteria (6 listed)
- periapical or palatal pathologies,
- absence teeth from canine to first molar,
- excessive forces including mechanical forces from orthodontics and occlusion,
- systemic diseases that would contraindicate for periodontal surgery or interfere with tissue healing, chronic high-dose steroid therapy, radiation or immunosuppressive therapy, pregnancy, lactation, smoking, or allergy or sensitivity to any drug
- Study participants had no history of drug therapy known to interfere with healing and to cause gingival enlargement
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 |
|---|---|---|
| Less than 2 mm remaining palatal tissue thicknessThe greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance. | Other | Less than 2 mm |
| 2 mm or more remaining palatal tissue thicknessThe greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance. | Other | 2 mm or more |
Primary outcome
Change in remaining palatal tissue thickness
Time frame: From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months
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 21 Jan 2016.
- Derived from this study: PubMed 27330024Keskiner I, Aydogdu A, Balli U, Kaleli AE. Quantitative changes in palatal donor site thickness after free gingival graft harvesting: a pilot study. J Clin Periodontol. 2016 Nov;43(11):976-984. doi: 10.1111/jcpe.12592. Epub 2016 Sep 9.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Less than 2 mm remaining palatal tissue thickness and 2 mm or more remaining palatal tissue thickness in people with Healthy and Gingival Recession, run by İlker KESKINER.
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 5 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 21 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in remaining palatal tissue thickness (time frame: From baseline remaining palatal tissue thickness to post-operative 1, 3, 6 months). 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 NCT02659904, 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 21 Jan 2016.