Wound HealingNCT06749119
The Effects of Age on Wound Healing on Free Gingival Graft Surgery in the Treatment of Attached Keratinized Gingival Deficiency by Determining Clinical and Biochemical Outcomes
A study testing Free gingival graft operation in people with Wound Healing and Tissue Grafts, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to assess the effects of age on wound healing on free gingival graft (FGG) surgery in the treatment of attached keratinized gingival deficiency by determining clinical and biochemical outcomes. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wound Healing, Tissue Grafts, Age
- What is being tested?
- Free gingival graft operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2023to 27 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having ≤2mm of keratinized gingiva in at least 1 mandibular anterior tooth
- periodontally healthy with full-mouth bleeding and plaque score ≤ 10%
- no use of any drugs that will affect periodontal tissue health and healing process
- absence of any systemic condition or illness
Who cannot join
- smokers
- previous periodontal surgery
- a pathology in the apical region of the tooth
- pregnancy, lactation
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry
Istanbul, Maltepe, 34854
About this study
Official title: Effect of Age on Recipient Site Wound Healing in Free Gingival Graft Operation
This study aimed to assess the effects of age on wound healing on free gingival graft (FGG) surgery in the treatment of attached keratinized gingival deficiency by determining clinical and biochemical outcomes.
Read the detailed description
Aim of this study was to evaluate the effect of age on clinical and biochemical healing outcomes on FGG surgery in the treatment of attached keratinized gingival deficiency (≤2 mm) at mandibular anterior region. A total of 30 systemically healthy patients, divided into two groups and planned for FGG operations, were included in this study. These groups are; Group l : 15 patients in the age range of 20-35, group 2: 15 patients in the age range of 50-65. Gingival crevicular fluid and wound fluid samples were taken from these patients to analyze VEGF, EGF and TGF-B1 levels by ELISA. Wound fluid samples were taken baseline, 4,7, and 14 days after surgery.
Clinical parameters included measurement of probing depth (PD), clinical attachment level (CAL), bleeding of probing (BOP), plaque index (PI), gingival index (GI) at 6 sites per tooth except the third molars were measured at baseline and l, 3 and 6 months after surgery. Keratinized gingiva width, keratinized gingiva thickness of the operation sites were measured baseline and 1,3 and 6 months after surgery. Vertical dimension of the graft, horizontal dimension of the graft, graft thickness were measured at baseline and 1,3,6 months after surgery. Graft area measurements were calculated on standard photographs by a Java-based analysis program (ImageJ, National Institutes of Health, Bethesda, MD) to determine the shrinkage rate of the grafts. The graft shrinkage ratio was calculated as the difference between baseline to 1-month, baseline to 3-months, baseline to 6-month graft site value. Data were analyzed using appropriate statistical tests.
- Conditions
- Wound Healing, Tissue Grafts, Age, Vegf, TGF-β
- Being tested
- Free gingival graft operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free gingival graft operationProcedure or surgery
Free gingival graft was harvested from palatal region and stabilized on the maxillary anterior recipient bed with sutures .
| Study group | Role | What they receive |
|---|---|---|
| Young group: Aged 20-35 years | Active comparator | They received free gingival operation. Graft was harvested from palatal region and placed to the recipient site. Wound fluid samples were collected from 4 regions of the wound at baseline, 4-,7-,14-days. Clinical measurements were done at baseline, 1-,3-,6-months postoperatively. Receives: Procedure: Free gingival graft operation |
| Adult group: Aged 50-65 years | Active comparator | They received free gingival operation. Graft was harvested from palatal region and placed to the recipient site. Wound fluid samples were collected from 4 regions of the wound at baseline, 4-,7-,14-days. Clinical measurements were done at baseline, 1-,3-,6-months postoperatively. Receives: Procedure: Free gingival graft operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shrinkage percentage (%)
Shrinkage percentage of the graft area due to the changes in graft dimensions
Measured: from baseline to 1-,3-,6- months
Secondary outcomes (3)
VEGF levels (pg/ml)
change in wound fluid VEGF levels from baseline to 1-,3-,6- months after surgery
Measured: from baseline to 1-,3-,6- months
EGF levels (pg/ml)
change in wound fluid EGF levels from baseline to 1-,3-,6- months after surgery
Measured: baseline to 1-,3-,6- months
TGFβ-1 levels (pg/ml)
change in wound fluid TGFβ-1 levels from baseline to 1-,3-,6- months after surgery
Measured: from baseline to 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 posted27 Dec 2024
- Study start14 Apr 2023
- Primary completion27 Dec 2024 (estimated)
- Study completion27 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound HealingStudies of the same condition, open and under way.
- More trials run by Marmara 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749119
- Sponsor's protocol ID
- 09.2020.660
- Status last verified
- Nov 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- 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 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on Recipient Site Wound Healing in Free Gingival Graft Operation
- ClinicalTrials.gov ID
- NCT06749119
- Acronym / sponsor ID
- 09.2020.660
- Conditions
- Wound Healing, Tissue Grafts, Age, Vegf, TGF-β
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 27 Dec 2024 (estimated)
- Study completion
- 27 Dec 2024 (estimated)
- First posted
- 27 Dec 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.
This study aimed to assess the effects of age on wound healing on free gingival graft (FGG) surgery in the treatment of attached keratinized gingival deficiency by determining clinical and biochemical outcomes.
Detailed description
Aim of this study was to evaluate the effect of age on clinical and biochemical healing outcomes on FGG surgery in the treatment of attached keratinized gingival deficiency (≤2 mm) at mandibular anterior region. A total of 30 systemically healthy patients, divided into two groups and planned for FGG operations, were included in this study. These groups are; Group l : 15 patients in the age range of 20-35, group 2: 15 patients in the age range of 50-65. Gingival crevicular fluid and wound fluid samples were taken from these patients to analyze VEGF, EGF and TGF-B1 levels by ELISA. Wound fluid samples were taken baseline, 4,7, and 14 days after surgery.
Clinical parameters included measurement of probing depth (PD), clinical attachment level (CAL), bleeding of probing (BOP), plaque index (PI), gingival index (GI) at 6 sites per tooth except the third molars were measured at baseline and l, 3 and 6 months after surgery. Keratinized gingiva width, keratinized gingiva thickness of the operation sites were measured baseline and 1,3 and 6 months after surgery. Vertical dimension of the graft, horizontal dimension of the graft, graft thickness were measured at baseline and 1,3,6 months after surgery. Graft area measurements were calculated on standard photographs by a Java-based analysis program (ImageJ, National Institutes of Health, Bethesda, MD) to determine the shrinkage rate of the grafts. The graft shrinkage ratio was calculated as the difference between baseline to 1-month, baseline to 3-months, baseline to 6-month graft site value. Data were analyzed using appropriate statistical tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Young group: Aged 20-35 years | Active comparator | Procedure: Free gingival graft operationThey received free gingival operation. Graft was harvested from palatal region and placed to the recipient site. Wound fluid samples were collected from 4 regions of the wound at baseline, 4-,7-,14-days. Clinical measurements were done at baseline, 1-,3-,6-months postoperatively. |
| Adult group: Aged 50-65 years | Active comparator | Procedure: Free gingival graft operationThey received free gingival operation. Graft was harvested from palatal region and placed to the recipient site. Wound fluid samples were collected from 4 regions of the wound at baseline, 4-,7-,14-days. Clinical measurements were done at baseline, 1-,3-,6-months postoperatively. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having ≤2mm of keratinized gingiva in at least 1 mandibular anterior tooth
- periodontally healthy with full-mouth bleeding and plaque score ≤ 10%
- no use of any drugs that will affect periodontal tissue health and healing process
- absence of any systemic condition or illness
Key exclusion criteria (4 listed)
- smokers
- previous periodontal surgery
- a pathology in the apical region of the tooth
- pregnancy, lactation
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 |
|---|---|---|
| Free gingival graft operationFree gingival graft was harvested from palatal region and stabilized on the maxillary anterior recipient bed with sutures . | Procedure or surgery | Adult group: Aged 50-65 years, Young group: Aged 20-35 years |
Primary outcome
Shrinkage percentage (%)
Time frame: from baseline to 1-,3-,6- months
Shrinkage percentage of the graft area due to the changes in graft dimensions
3 secondary outcomes
VEGF levels (pg/ml)
Time frame: from baseline to 1-,3-,6- months
EGF levels (pg/ml)
Time frame: baseline to 1-,3-,6- months
TGFβ-1 levels (pg/ml)
Time frame: from baseline to 1-,3-,6- months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 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 Free gingival graft operation in people with Wound Healing and Tissue Grafts, run by Marmara 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 4 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 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?
This study is still under way. Results are not available in the source record yet.
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?
Shrinkage percentage (%) (time frame: from baseline to 1-,3-,6- months). 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 27 Dec 2024.