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Soft Tissue AugmentationNCT07777185

Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts

A study testing Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG) in people with Soft Tissue Augmentation and Gingival Recession Localized Moderate, run by Ankara University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This single-center prospective clinical study investigates how smoking affects palatal donor site tissue biology and, in turn, the success of connective tissue grafts used in root coverage surgery. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Coronally Advanced Flap with Subepithelial 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
24 participants
Where
1 siteTurkey (Türkiye)
Study dates
20 Oct 2026to 20 Feb 2027
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Aged 18 years or older.
  • Systemically healthy, with no systemic disease that could directly affect status or wound healing.
  • Presence of an isolated facial recession on non-molar maxillary teeth:
  • greater than 2 mm, less than 5 mm (up to a maximum of 5 mm).
  • Recession classified as Cairo Type 1 (RT1 = Miller Class I and II), meaning gingival recession without interproximal attachment loss.
  • No previous soft tissue surgery at the surgical site.
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  • Good oral hygiene (full-mouth bleeding on probing below 10%).
  • No soft tissue graft previously harvested from the palatal donor site.
  • Able to comply with all study-related procedures, including attendance at all follow-up visits.

Who cannot join

  • Untreated periodontitis or peri-implantitis.
  • Any systemic disease that could potentially impair wound healing, such as diabetes or connective tissue disorders.
  • Pregnancy or breastfeeding.
  • Previous or concurrent use of medications affecting mucosal healing (e.g., steroids or high-dose anti-inflammatory drugs).
  • Coagulation or bleeding disorders.
  • Cleft palate.
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  • Active orthodontic treatment with fixed or removable appliances.
  • A history of malignancy, radiotherapy, or chemotherapy for malignancy within the past 5 years.
  • Antibiotic therapy within the past 6 months.
  • Previous connective tissue graft harvested from the palatal donor site.
  • Any other surgical procedure at the palatal donor or recipient site (e.g., apical resection or crown lengthening).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Sivge Kurgan, PhD contact

+905325495235

sivgeakgun@gmail.com

Husna OKTOPCU KARAKOYUN, DDS contact

+905397835782

husnaansuh34@outlook.com

Turkey (Türkiye)1 site
  • Ankara University Faculty of Dentistry

    Ankara, Yenimahalle, 06560

    Elif Unsal, PhD, +905337627542, unsal.e@gmail.com

    Husna OKTOPCU KARAKOYUN, DDS, +905397835782, husnaansuh34@outlook.com

Other trials in Turkey (Türkiye)

About this study

Official title: Evaluation of the Effect of Smoking on the Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts

This single-center prospective clinical study investigates how smoking affects palatal donor site tissue biology and, in turn, the success of connective tissue grafts used in root coverage surgery. A total of 24 systemically healthy patients with Cairo Type 1 (recession type 1 [RT1]) gingival recession will be enrolled: 12 smokers and 12 non-smokers. All participants will receive a coronally advanced flap combined with a subepithelial connective tissue graft (CAF + CTG) harvested from the palatal donor site.

Both donor and recipient sites will be assessed at baseline and postoperatively (2 weeks, 1 month, and 3 months) using ultra-high frequency ultrasonography (UHFUS) to measure tissue thickness, echogenicity, structural integrity, and vascularization. Residual connective tissue fragments obtained during routine graft preparation will undergo histological, histochemical, and immunohistochemical analysis (including COL1A1, COL1A2, COL3A1, α-SMA, CD31, Factor XIIIa, and IL-33). Smoking status will be biochemically confirmed via salivary cotinine enzyme-linked immunosorbent assay (ELISA). Clinical outcomes (recession depth, clinical attachment level, keratinized tissue height, percentage of root coverage) and patient-reported outcome measures (PROMs) will be compared between groups.

Primary Hypothesis: Smoking negatively affects palatal donor site biology, impairing the clinical and ultrasonographic healing outcomes of CAF + CTG procedures.

Read the detailed description

Gingival recession, particularly in the esthetic zone, exposes root surfaces and leads to root hypersensitivity, esthetic impairment, and reduced periodontal stability. The coronally advanced flap combined with a subepithelial connective tissue graft (CAF + CTG) is considered the gold standard for root coverage, offering high rates of long-term root coverage and soft tissue volume gain. Smoking is a well-recognized patient-level factor that adversely affects wound healing through its impact on vascularization, fibroblast activity, and collagen metabolism, potentially compromising both the biological integrity of the donor graft and its integration at the recipient site. However, the relationship between these clinical differences and the underlying biology of the palatal donor site remains poorly understood. This single-center, prospective, controlled clinical study aims to examine the relationship between palatal donor site biology and connective tissue graft success using an integrated clinical, ultrasonographic, histological, and molecular approach, with the central hypothesis that smoking negatively affects donor site biology and thereby impairs the clinical and ultrasonographic healing outcomes of CAF + CTG procedures. A total of 24 systemically healthy patients presenting with Cairo Type 1 (recession type 1 [RT1] / Miller Class I-II) gingival recession and requiring root coverage for esthetic concerns or root hypersensitivity will be enrolled and allocated into two groups of 12: smokers (≥20 cigarettes/day for at least 5 years, biochemically confirmed by salivary cotinine) and non-smokers. The sample size was determined via G*Power (α = 0.05, effect size = 0.4, power = 0.95), yielding a minimum of 10 subjects per group, increased to 12 to account for potential dropout, and all patients will be followed for 3 months under standardized imaging and biological sampling protocols.

Every participant will receive the same standardized surgical protocol: a coronally advanced flap with a subepithelial connective tissue graft harvested from the palatal donor site between the second premolar and second molar using an extraoral de-epithelialization approach, with root surfaces conditioned using 24% ethylenediaminetetraacetic acid (EDTA), following a previously described technique. Ultra-high frequency ultrasonography (LOGIQ P10 XDClear with an L8-18i-RS high-frequency linear probe) will be performed at both the palatal donor site and the recipient site at baseline and at 2 weeks, 1 month, and 3 months postoperatively, with custom three-dimensional (3D)-printed surgical stents standardizing probe positioning for reproducibility. The ultrasonographic evaluation includes Doppler and B-Flow color quantification of vascularization and blood flow, linear measurements of epithelial thickness, lamina propria thickness, and total soft tissue thickness at the donor site along with marginal mucosal, flap, and graft thickness at the recipient site, and echo intensity analysis of mean gray value, tissue homogeneity, and structural integrity performed with ImageJ.

Residual connective tissue fragments naturally trimmed during routine graft preparation, which require no additional surgical intervention or patient morbidity, will be collected for laboratory analysis. These samples will undergo morphological evaluation with hematoxylin-eosin, histochemical assessment of extracellular matrix organization with Masson's Trichrome and collagen typing with Picrosirius Red under polarized light to distinguish Type I from Type III collagen, and immunohistochemical evaluation of collagen type I alpha 1 (COL1A1), collagen type I alpha 2 (COL1A2), and collagen type III alpha 1 (COL3A1) for collagen matrix, alpha-smooth muscle actin (α-SMA) for fibroblast and myofibroblast activity, Factor XIIIa for extracellular matrix stabilization and graft integration, cluster of differentiation 31 (CD31) for microvascular density, and interleukin-33 (IL-33) for inflammatory signaling.

Blinded clinical measurements including recession depth, recession width, pocket depth, clinical attachment level, keratinized tissue height, bleeding on probing, plaque index, and percentage of root coverage will be recorded at baseline, 1 month, and 3 months. Patient-reported outcome measures will capture postoperative pain, donor site discomfort, functional recovery, esthetic satisfaction, and analgesic consumption, and salivary samples for cotinine enzyme-linked immunosorbent assay (ELISA) will be collected before surgery and at 1 month to biochemically verify smoking status. Through this multidimensional design, the study will characterize how palatal donor site biology shapes connective tissue graft success and will scientifically define the role of smoking in these processes, contributing to the development of personalized, biology-based treatment approaches in periodontal plastic surgery.

Being tested
Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)Procedure or surgery

    All defects are treated by a single experienced periodontist using microsurgical All defects are treated by a single experienced periodontist following the technique of Cairo et al. (2012). After local anesthesia, root surfaces are debrided, conditioned with 24% EDTA for 2 minutes, and rinsed. Vertical releasing and intrasulcular incisions are made; a full-thickness flap is raised to the mucogingival junction, then split-thickness dissection allows coronal advancement. A subepithelial connective tissue graft (0.5-1 mm) is harvested from the palate, adapted to the root surface, and secured with sutures, and the flap is positioned 1-2 mm coronal to the cemento-enamel junction.

Study groups in NCT07777185
Study groupRoleWhat they receive
Group 1 - Non-smokersActive comparatorSystemically and periodontally healthy non-smoking patients requiring root coverage treatment due to esthetic concerns or root hypersensitivity, treated with a coronally advanced flap combined with a subepithelial connective tissue graft (CAF + CTG) harvested from the palatal donor site (n = 12).
Receives: Procedure: Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)
Group 2 - SmokersExperimentalSystemically and periodontally healthy smoking patients requiring root coverage treatment due to esthetic concerns or root hypersensitivity, treated with the same coronally advanced flap combined with a subepithelial connective tissue graft (CAF + CTG) harvested from the palatal donor site (n = 12). Participants are classified as smokers if they report smoking ≥20 cigarettes per day (one pack per day) for at least 5 years, confirmed biochemically by salivary cotinine analysis.
Receives: Procedure: Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Root Coverage

    The percentage of root coverage achieved at the treated site, calculated as [(preoperative recession depth - postoperative recession depth) / preoperative recession depth] × 100. Recession depth is measured with a calibrated UNC-15 periodontal probe as the distance from the cemento-enamel junction to the gingival margin. This is the principal clinical measure of treatment success and allows direct comparison of graft effectiveness between smokers and non-smokers.

    Measured: Time Frame: Baseline to 3 months postoperatively

Secondary outcomes (3)
  1. Ultrasonographic Soft Tissue Thickness at the Donor and Recipient Sites

    Quantitative change in soft tissue thickness measured non-invasively with ultra-high frequency ultrasonography (UHFUS), including epithelial thickness, lamina propria thickness, and total soft tissue thickness at the palatal donor site, and marginal mucosal, flap, and graft thickness at the recipient site. Measurements are standardized using custom 3D-printed surgical stents. This outcome captures tissue healing dynamics and volumetric stability over time.

    Measured: Baseline, 2 weeks, 1 month, and 3 months postoperatively

  2. Donor Site Tissue Vascularization

    Quantitative assessment of blood flow and microvascularization at the palatal donor site using Color Doppler / B-Flow ultrasonography, analyzed with integrated Color Quantification software within a standardized region of interest. Vascularization is a key indicator of donor site healing capacity and is expected to be reduced in smokers.

    Measured: Baseline, 2 weeks, 1 month, and 3 months postoperatively

  3. Donor Site Histological and Immunohistochemical Tissue Profile

    Characterization of the palatal donor tissue obtained from residual connective tissue fragments trimmed during routine graft preparation. This includes collagen organization and Type I/Type III collagen ratio (Picrosirius Red under polarized light), extracellular matrix organization (Masson's Trichrome), microvascular density (CD31), fibroblast/myofibroblast activity (α-SMA), matrix stabilization (Factor XIIIa), collagen expression (COL1A1, COL1A2, COL3A1), and inflammatory signaling (IL-33). This outcome defines how donor site biology differs between smokers and non-smokers.

    Measured: At the time of surgery (single time point)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2026
  2. Study start20 Oct 2026 (estimated)
  3. Primary completion20 Feb 2027 (estimated)
  4. Study completion20 Feb 2027 (estimated)

Resources

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
Investigator, Outcomes assessor
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07777185
Sponsor's protocol ID
İ01-36-26
Other IDs
TDH-2026-4827
Status last verified
Oct 2026
First submitted
17 Aug 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cairo F, Cortellini P, Tonetti M, Nieri M, Mervelt J, Cincinelli S, Pini-Prato G. Coronally advanced flap with and without connective tissue graft for the treatment of single maxillary gingival recession with loss of inter-dental attachment. A randomized controlled clinical trial. J Clin Periodontol. 2012 Aug;39(8):760-8. doi: 10.1111/j.1600-051X.2012.01903.x. Epub 2012 May 28.

    PubMed 22639845

Questions about this trial

What is this clinical trial studying?

A study testing Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG) in people with Soft Tissue Augmentation and Gingival Recession Localized Moderate, run by Ankara 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 9 inclusion and 11 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 14 Oct 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 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?

Contact Sivge Kurgan, PhD (+905325495235, sivgeakgun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Root Coverage (time frame: Time Frame: Baseline to 3 months postoperatively). 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 NCT07777185, 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 14 Oct 2026.

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