Evaluation of the Effect of Smoking on Palatal Donor Site Tissue Profile in the Success of Connective Tissue Grafts
2 other identifiers
interventional
24
1 country
1
Brief 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. 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2026
CompletedStudy Start
First participant enrolled
August 18, 2026
CompletedFirst Posted
Study publicly available on registry
August 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 17, 2027
August 25, 2026
August 1, 2026
6 months
August 17, 2026
August 24, 2026
Conditions
Outcome Measures
Primary Outcomes (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.
Time Frame: Baseline to 3 months postoperatively
Secondary Outcomes (3)
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)
Study Arms (2)
Group 1 - Non-smokers
ACTIVE 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).
Group 2 - Smokers
EXPERIMENTALSystemically 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University Faculty of Dentistry
Ankara, Yenimahalle, 06560, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 22639845BACKGROUND
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant, Departmant of Periodontology
Study Record Dates
First Submitted
August 17, 2026
First Posted
August 20, 2026
Study Start
August 18, 2026
Primary Completion (Estimated)
February 17, 2027
Study Completion (Estimated)
February 17, 2027
Last Updated
August 25, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share