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

StatusNot Yet Recruiting
PhaseNot applicable
Started2026-08-18
View on ClinicalTrials.gov ↗

Amendment history

2026-08-24
minor
Study Status, Study Description, Eligibility, References v1
Eligibility criteria-332 characters
Inclusion Criteria: Participants must be agedAged 18 years or older and systemically. Systemically healthy, with no systemic disease that could directly affect inflammatory status or wound healing. EligiblePresence patients must present withof an isolated facial recession on non-molar maxillary teeth: greater than 2 mm and, less than 5 mm (up to a maximum of 5 mm) on non-molar maxillary teeth,. Recession classified as Cairo Type 1 (RT1 = Miller Class I and II), m [...] g gingival recession without interproximal attachment loss. Patients must have had noNo previous soft tissue surgery at the surgical [...] [...]
Study description+252 characters
[...] systemically healthy patients presenting with Cairo Type 1 (recession type 1 [RT1] / Miller Class I-II) gingival recession and requiring root [...] lization approach, with root surfaces conditioned using 24% ethylenediaminetetraacetic acid (EDTA), following thea techniquepreviously described by Cairo et al. (2012)technique. Ultra-high frequency ultrasonography (LOGIQ P10 XDClear wi [...] 2 weeks, 1 month, and 3 months postoperatively, with custom three-dimensional (3D)-printed surgical stents standardizing probe positioning for [...] om Type III collagen, and immunohistochemical evaluation of collagen type I alph [...] [...]
2026-08-17
minor
Original filing
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.
Trial Details
NCT Number NCT07777185
Lead Sponsor Ankara University
Conditions Soft Tissue Augmentation, Gingival Recession Localized Moderate, Palatal Morphology
Enrollment 24 participants
Start Date 2026-08-18
Primary Completion 2027-02-17 (estimated)
Study Completion 2027-02-17 (estimated)
Updated on ClinicalTrials.gov 2026-08-25