An interventional study of Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG) in Soft Tissue Augmentation, Gingival Recession Localized Moderate and Palatal Morphology, sponsored by Ankara University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-14.
Sponsored by Ankara University · Not applicable, Interventional, and Treatment
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.
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.
426 studies on the registry are indexed under Gingival Recession; 106 are open to participants now.
This study's planned enrollment of 24 is below the median of 30 across 390 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Ankara University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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).
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Procedure: Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)
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.
Procedure: Coronally Advanced Flap with Subepithelial Connective Tissue Graft (CAF + CTG)
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.
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: Time Frame: Baseline to 3 months postoperatively
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.
Time frame: Baseline, 2 weeks, 1 month, and 3 months postoperatively
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.
Time frame: Baseline, 2 weeks, 1 month, and 3 months postoperatively
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.
Time frame: At the time of surgery (single time point)
Plan to share: No
Start is estimated for Oct 2026; primary completion for Feb 2027, 4 months later.
Of 233 non-industry interventional studies with no phase under Gingival Recession, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 4 months is below that.
Counting every sponsor, half of 235 studies reached it within 19 months; a quarter within 11 and three quarters within 30.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Oct 2026, on Oct 14, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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