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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Ankara University Scientific Research Project Unit
interventional
24
1 country
1
Study Start
October 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
February 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2026
Actual (reported)August 20, 2026
Actual (reported)October 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Time Frame: Baseline to 3 months postoperatively
Ultrasonographic Soft Tissue Thickness at the Donor and Recipient Sites
Baseline, 2 weeks, 1 month, and 3 months postoperatively
Donor Site Tissue Vascularization
Baseline, 2 weeks, 1 month, and 3 months postoperatively
Donor Site Histological and Immunohistochemical Tissue Profile
At the time of surgery (single time point)
Systemically 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).
Systemically 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.
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.
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Ankara University Faculty of Dentistry
Ankara, Yenimahalle, 06560, Turkey (Türkiye)
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.
First Submitted
August 17, 2026
First Posted
August 20, 2026
Study Start
October 20, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Contact the study team to confirm eligibility.
February 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 20, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 14, 2026
Record last verified: 2026-10
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