Gingival Recession
Conditions
Brief summary
This study aims to evaluate whether the method of root surface preparation influences surgical outcomes. It will assess whether manual root instrumentation can be replaced by a less invasive erythritol air-polishing technique.
Interventions
PROCEDUREErythritol Air-Polishing
Root surface preparation performed using erythritol powder air-polishing (EMS AIRFLOW PLUS) prior to root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.
PROCEDUREManual Root Instrumentation
Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.
Sponsors
Medical University of Warsaw
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Multiple RT1 and/or RT2 gingival recessions, symmetrical and bilateral, with a minimum height of ≥ 1 mm * Full-mouth plaque score (FMPS) \< 15% (assessed on four surfaces per tooth) * Full-mouth bleeding on probing (FMBOP) \< 15% (assessed on four surfaces per tooth) * Detectable cemento-enamel junction (CEJ) * Age ≥ 18 years
Exclusion criteria
* RT3 gingival recessions * Gingival recessions affecting second and third molars * Systemic or infectious diseases that may impair wound healing, including active malignancy, diabetes mellitus with HbA1c \> 7.0%, history of head and neck radiotherapy, true xerostomia, and HIV/AIDS * Cervical caries, non-carious cervical lesions, or Class V restorations interfering with the CEJ * Active periodontitis * Use of medications affecting periodontal tissues or wound healing, including systemic corticosteroids, immunosuppressants, isotretinoin, bisphosphonates, and monoclonal antibodies with immunosuppressive, antiresorptive, or antiangiogenic effects * Smoking * Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Root Coverage (MRC, %) | 6 months and 12 months post-surgery | Mean root coverage (MRC), expressed as a percentage (%), assessed at 6 and 12 months post-surgery. MRC is calculated as (GR₀ - GR₆) / GR₀ × 100% and (GR₀ - GR₁₂) / GR₀ × 100%, respectively. Gingival recession (GR), measured in millimeters (mm) as the distance from the cemento-enamel junction (CEJ) to the gingival margin at the mid-buccal aspect of the tooth, is used solely as an input parameter for the calculation of MRC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gingival recession height (GRH, mm) | baseline, 6 months, and 12 months post-surgery | Distance from the cemento-enamel junction (CEJ) to the gingival margin measured at the mid-buccal aspect of the tooth. |
| Gingival recession width (RW, mm) | baseline, 6 months, and 12 months post-surgery | Horizontal distance measured at the level of the cemento-enamel junction (CEJ) between the mesial and distal margins of the gingival recession. |
| Clinical Attachment Level (CAL, mm) | Baseline; 6 and 12 months post-surgery | Distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus. |
| Probing Pocket Depth (PPD, mm) | baseline, 6 months, and 12 months post-surgery | Distance from the gingival margin to the bottom of the gingival sulcus. |
| Gingival Thickness (GT, mm) | baseline, 6 months, and 12 months post-surgery | Thickness of the gingiva measured 3 mm apical to the gingival margin at the mid-buccal aspect of the tooth. |
| Keratinized tissue width (KTW, mm) | baseline, 6 months, and 12 months post-surgery | Distance from the gingival margin to the mucogingival junction |
| Complete Root Coverage (CRC, %) | 6 months and 12 months post-surgery | % CRC = (number of teeth with CRC = 1 after treatment / total number of teeth with gingival recession at baseline) × 100. CRC = 1: postoperative GR ≤ 0 mm, indicating complete root coverage. CRC = 0: postoperative GR \> 0 mm, indicating partial or no root coverage. |
| Gingival Recession Reduction (GR red, mm) | 6 months and 12 months post-surgery | Reduction in recession height at 6 months: GR₀ - GR₆ Reduction in recession height at 12 months: GR₀ - GR₁₂ |
| Clinical Attachment Level Gain (CAL Gain, mm) | 6 months and 12 months post-surgery | Clinical attachment level gain at 6 months = CAL₀ - CAL₆ Clinical attachment level gain at 12 months = CAL₀ - CAL₁₂ |
| Keratinized Tissue Width Gain (KTW Gain, mm) | 6 months and 12 months post-surgery | Increase in keratinized tissue width at 6 months: KTW₆ - KTW₀ Increase in keratinized tissue width at 12 months: KTW₁₂ - KTW₀ |
| Tooth Sensitivity (SEN, Schiff score) | Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery. | Clinician-assessed tooth sensitivity evaluated using the Schiff Cold Air Sensitivity Scale. Air will be delivered using a standard air syringe of the dental unit, positioned approximately 1 cm from the tooth surface for 5 seconds, at a working temperature of 23 °C (±4 °C), and directed at the exposed buccal surface of the tooth with gingival recession. Patient response to the air stimulus will be assessed by the clinician using the Schiff Cold Air Sensitivity Scale as follows: 0 = No response to the air stimulus 1. = Response to the air stimulus, but no request to discontinue the stimulus 2. = Response to the air stimulus, with a request to discontinue the stimulus and/or turning away from the stimulus 3. = Painful response to the air stimulus, with a request to discontinue the stimulus |
| Root Esthetic Score (RES, score) | 6 and 12 months after surgery | Root Esthetic Score (RES), expressed as a composite score ranging from 0 to 10 points. The RES is a clinician-assessed composite esthetic outcome comprising the following five components: 1. Gingival Margin (GM): failure of root coverage (0 points), partial root coverage (3 points), complete root coverage (6 points); 2. Marginal Tissue Contour (MTC): irregular gingival margin not following the cemento-enamel junction (CEJ) (0 points), scalloped gingival contour following the CEJ (1 point); 3. Soft Tissue Texture (STT): presence of scar (0 points), absence of scars (1 point); 4. Mucogingival Junction (MGJ): MGJ not aligned with the MGJ of adjacent teeth (0 points), MGJ aligned with the MGJ of adjacent teeth (1 point); 5. Gingival Color (GC): color mismatch with adjacent teeth (0 points), color matching adjacent teeth (1 point). The total RES score is calculated as the sum of all component scores, with higher scores indicating a better esthetic outcome. |
| Discomfort during the procedure (VAS, 0-10) | Immediately after completion of the procedure | Patient-reported discomfort during the procedure assessed using the Visual Analogue Scale (VAS; 0 = no discomfort, 10 = extreme discomfort). |
| Pain intensity (VAS scale, 0-10) | 1, 2, 4, 7, 14 days after procedure | Patient-reported pain intensity assessed using the Visual Analogue Scale (VAS; 0 = no pain, 10 = maximum pain). |
| Postoperative swelling (VAS scale, 0-10) | 1, 2, 4, 7, 14 days after procedure | Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum). |
| Tooth sensitivity (VAS, 0-10) | 1, 2, 4, 7, and 14 days post-procedure | Patient-reported tooth sensitivity assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum). |
| Gingival color (VAS, 0-10) | 6 and 12 months post-surgery | Patient-reported gingival color assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent). |
| Gingival shape (VAS 0-10) | 6 and 12 months post-surgery | Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent) |
| Tooth appearance (VAS, 0-10) | 6 and 12 months post-surgery | Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent). |
Countries
Poland
Contacts
CONTACTMagdalena Latkowska - Wiśniewska
CONTACTBartłomiej Górski
STUDY_CHAIRBartłomiej Górski
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Outcome results
None listed