Diabetes MellitusNCT07470281
Oral Mucosa Wound Healing After Gingival Recession Treatment in Diabetic Patients. A Clinical Study.
A study testing Coronally Advance Flap associated with connective tissue graft (CAF+CTG) in people with Diabetes Mellitus and Gingival Recession, Generalized, run by Mauro Santamaria at 1 site in United States.
Trial summary
The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment in diabetic patients and to compare them with those in non-diabetic patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Gingival Recession, Generalized, Gingival Recession, Localized
- What is being tested?
- Coronally Advance Flap associated with connective tissue graft (CAF+CTG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Apr 2030
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged ≥ 18 years;
- non-diabetic and diabetic patients (HbA1c>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
- in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
- periodontal stable (BoP ≤25%)(Lang et al. 2003);
- no morphological or pathological conditions in the palatal mucosa.
Who cannot join
- patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
- taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Pregnancy/lactation (assessed via self-report);
- current opportunistic oral lesions that mainly colonize the palate region;
- subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
- prisoners;
- signs or symptoms of active extra-oral head and neck infection (swelling) as determined by a dentist at the time of evaluation;
- subjects who cannot read or speak English or Spanish, and do not agree to having the assistance of an interpreter
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
College of Dentistry - University of Kentucky
Lexington, Kentucky, 40536
Mauro Pedrine Santamaria, DDS, Ms, PhD, 859 323 6297, maurosantamaria@uky.edu
Dawn Dawson, 859 323-5409, dawn.dawson@uky.edu
About this study
Official title: Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Closed Wounds
The goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment in diabetic patients and to compare them with those in non-diabetic patients.
Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are:
Read more
- If the gingival recession reduction and percentage of root coverage are different in diabetics compared to non-diabetics.
- If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome.
Participants will be asked:
- Receive the procedure to treat their gingival recession defects
- To attend follow-up visits at 7, 14, 30, 90, and 180 days after treatment.
- To provide different biological samples
- To answer different questionnaires.
- Being tested
- Coronally Advance Flap associated with connective tissue graft (CAF+CTG)
- Keywords
- gingival recession, Diabetes, wound healing
- Medical subject headings
- Diabetes Mellitus, Gingival Recession
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronally Advance Flap associated with connective tissue graft (CAF+CTG)Procedure or surgery
A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ
| Study group | Role | What they receive |
|---|---|---|
| Diabetes group | Experimental | Not described Receives: Procedure: Coronally Advance Flap associated with connective tissue graft (CAF+CTG) |
| Non-diabetes group | Active comparator | Not described Receives: Procedure: Coronally Advance Flap associated with connective tissue graft (CAF+CTG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
gingival recession reduction
The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values
Measured: 6 months
Secondary outcomes (9)
Probing depth
measured in millimeters using a periodontal probe at the mid-buccal aspect
Measured: 6 month
Clinical attachment level
measured as probing depth + gingival recession
Measured: 6 months
PROMIS Adult Sleep Disturbance Survey
The Patient-Reported Outcomes Measurement Information System (PROMIS) sleep disturbance survey has each item on the measure is rated on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with a range in score from 8 to 40 with higher scores indicating greater severity of sleep disturbance.
Measured: Baseline and up to 4 weeks
Insomnia Severity Index Survey
The insomnia survey scores range from 0 to 28 with a higher score indicating greater insomnia.
Measured: Baseline and up to 4 weeks
Change in Dentin hypersensitivity
The participants may be asked about the dentin hypersensitivity in the gingival recession site after a 3-second air blast and self-report esthetic perceptions before the surgery and 3 and 6 months after the surgical protocol.
Measured: Baseline and up to 6 months
Number of analgesics
Number of analgesics taken on the current day for 7 days.
Measured: 7 days
Discomfort
Participants will be asked to report the discomfort level using a visual analog scale for 7 days after the surgery. Scale ranges from 0 to 10 with a higher score equating to increased discomfort.
Measured: 7 days
Root Coverage Esthetic Score
The aesthetics of the site will be assessed using the Root Coverage Esthetic - RES Score visually with score (0 "minimum" - 10 "maximum"). A higher score equates to a better esthetic outcome.
Measured: 6 months
gingival crevicular fluid (GCF) inflammatory markers
The gingival crevicular fluid (GCF) may be collected from the Gingival Recession defect sites before the surgery (visit 1), and 1-,2-, 4-, 12-, 24-weeks after the procedure. Two paper strips (periopaper, Oraflow, Inc.) will be inserted gently into the sulcus for 30 seconds. Before sampling, the area will be gently rinsed and dried using water and an air spray.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionApr 2029 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauro Santamaria
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauro Santamaria, University of Kentucky
- Investigators
- Mauro Santamaria, DDS, MS, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470281
- Sponsor's protocol ID
- 109004
- Status last verified
- May 2026
- First submitted
- 9 Mar 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) underlying the results reported in this study, including demographic variables, baseline characteristics, clinical measurements, outcome variables, and relevant covariates. may be made available upon a reasonable request.
Publications
Meyer MD, Coelho RMI, Rangel-Coelho JP, Costa BC, Teixeira LN, Martinez EF, Casarin RCV, Santamaria MP, Franca FMG, Nociti-Jr FH, Lisboa-Filho PN, Kantovitz KR. Titanium dioxide nanotubes incorporated into conventional glass ionomer cement alter the biological behavior of pre-odontoblastic cells. Colloids Surf B Biointerfaces. 2025 Feb;246:114389. doi: 10.1016/j.colsurfb.2024.114389. Epub 2024 Nov 20.
PubMed 39591848Santamaria MP, Mathias-Santamaria IF, Tavelli L, Barootchi S, Prato GPP. An updated evidence-based recommendation for the treatment of gingival recession associated with non-carious cervical lesions. J Periodontol. 2026 May;97(5):1010-1025. doi: 10.1002/jper.70049. Epub 2026 Jan 7.
PubMed 41498281
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Mucosa Wound Healing in Diabetic Patients. A Clinical Study on Closed Wounds
- ClinicalTrials.gov ID
- NCT07470281
- Acronym / sponsor ID
- 109004
- Keywords
- gingival recession, Diabetes, wound healing
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mauro SantamariaUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2029 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 13 Mar 2026 (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 goal of this clinical trial is to evaluate local and systemic factors involved in oral mucosal healing after gingival recession treatment in diabetic patients and to compare them with those in non-diabetic patients.
Diabetic and non-diabetic volunteers of both sexes aged ≥ 18 years with gingival recession may participate. The main questions it aims to answer are:
- If the gingival recession reduction and percentage of root coverage are different in diabetics compared to non-diabetics.
- If different factors, such as the oral microbiome, inflammatory markers, and others, are associated with the clinical outcome.
Participants will be asked:
- Receive the procedure to treat their gingival recession defects
- To attend follow-up visits at 7, 14, 30, 90, and 180 days after treatment.
- To provide different biological samples
- To answer different questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diabetes group | Experimental | Procedure: Coronally Advance Flap associated with connective tissue graft (CAF+CTG) |
| Non-diabetes group | Active comparator | Procedure: Coronally Advance Flap associated with connective tissue graft (CAF+CTG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged ≥ 18 years;
- non-diabetic and diabetic patients (HbA1c>7% (American Diabetes Association 2025) managed with oral hypoglycemic agents or insulin;
- in the need of gingival recession treatment (RT1) in upper or lower arches with identifiable or restored cement-enamel junction (CEJ);
- periodontal stable (BoP ≤25%)(Lang et al. 2003);
- no morphological or pathological conditions in the palatal mucosa.
Key exclusion criteria (8 listed)
- patients with cardiovascular, blood dyscrasias, and immunodeficiency that contraindicate surgical procedures;
- taking medications known to interfere with the wound healing process or that contraindicate the surgical procedure;
- Pregnancy/lactation (assessed via self-report);
- current opportunistic oral lesions that mainly colonize the palate region;
- subjects that have taken antibiotics within the last 3 months or need for antibiotic prophylaxis;
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 |
|---|---|---|
| Coronally Advance Flap associated with connective tissue graft (CAF+CTG)A CAF will be performed following the gingival recession (GR) defect features extending beyond the mucogingival junction (MGJ) in a split-full-split thickness design. In sequence, a 2-mm thick free gingival graft (FGG), measuring 15 × 5 mm, will be harvested from the palatal area between the distal of the canine and the mesial aspect of the first molar. The FGG will be trimmed based on the GR defect features and de-epithelialized to achieve a final thickness of 1 mm. The de-epithelialized graft (CTG) will be sutured in position, at the level of the cement-enamel junction (CEJ), using interrupted absorbable sutures. Finally, the flap margin will be repositioned 2 mm coronal to CEJ | Procedure or surgery | Diabetes group, Non-diabetes group |
Primary outcome
gingival recession reduction
Time frame: 6 months
The amount of reduction in the gingival recession defect. It is calculated by subtracting the final gingival recession values from the initial values
9 secondary outcomes
Probing depth
Time frame: 6 month
Clinical attachment level
Time frame: 6 months
PROMIS Adult Sleep Disturbance Survey
Time frame: Baseline and up to 4 weeks
Insomnia Severity Index Survey
Time frame: Baseline and up to 4 weeks
Change in Dentin hypersensitivity
Time frame: Baseline and up to 6 months
Number of analgesics
Time frame: 7 days
Discomfort
Time frame: 7 days
Root Coverage Esthetic Score
Time frame: 6 months
gingival crevicular fluid (GCF) inflammatory markers
Time frame: 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 24 Aug 2026.
- Background: PubMed 39591848Meyer MD, Coelho RMI, Rangel-Coelho JP, Costa BC, Teixeira LN, Martinez EF, Casarin RCV, Santamaria MP, Franca FMG, Nociti-Jr FH, Lisboa-Filho PN, Kantovitz KR. Titanium dioxide nanotubes incorporated into conventional glass ionomer cement alter the biological behavior of pre-odontoblastic cells. Colloids Surf B Biointerfaces. 2025 Feb;246:114389. doi: 10.1016/j.colsurfb.2024.114389. Epub 2024 Nov 20.
- Background: PubMed 41498281Santamaria MP, Mathias-Santamaria IF, Tavelli L, Barootchi S, Prato GPP. An updated evidence-based recommendation for the treatment of gingival recession associated with non-carious cervical lesions. J Periodontol. 2026 May;97(5):1010-1025. doi: 10.1002/jper.70049. Epub 2026 Jan 7.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) underlying the results reported in this study, including demographic variables, baseline characteristics, clinical measurements, outcome variables, and relevant covariates. may be made available upon a reasonable request.
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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.
Mauro Santamaria, DDS, MS, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronally Advance Flap associated with connective tissue graft (CAF+CTG) in people with Diabetes Mellitus and Gingival Recession, Generalized, run by Mauro Santamaria at 1 site in United States.
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 8 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: opening soon, as of the sponsor's last update on 24 Aug 2026. 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 United States. 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?
Contact Dawn G Dawson (8593235409, dawn.dawson@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gingival recession reduction (time frame: 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 NCT07470281, which also lists 2 linked publications.
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 24 Aug 2026.