Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Warsaw, Mazowsze, 00-246, Poland
Location status: Recruiting
NCT Number: NCT07403006
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Warsaw, Mazowsze, 00-246, Poland
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline; 6 and 12 months post-surgery
Distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus.
Time frame: baseline, 6 months, and 12 months post-surgery
Distance from the gingival margin to the bottom of the gingival sulcus.
Time frame: 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.
Time frame: baseline, 6 months, and 12 months post-surgery
Distance from the gingival margin to the mucogingival junction
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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:
The total RES score is calculated as the sum of all component scores, with higher scores indicating a better esthetic outcome.
Time frame: 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).
Time frame: 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).
Time frame: 1, 2, 4, 7, 14 days after procedure
Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).
Time frame: 1, 2, 4, 7, and 14 days post-procedure
Patient-reported tooth sensitivity assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).
Time frame: 6 and 12 months post-surgery
Patient-reported gingival color assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).
Time frame: 6 and 12 months post-surgery
Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent)
Time frame: 6 and 12 months post-surgery
Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).
Time frame: Baseline (day of surgery, pre-anesthesia)
Patient-reported procedure-related stress assessed using the Visual Analogue Scale (VAS; 0 = no stress, 10 = extreme stress).
Time frame: 12 months after surgery
Patient-reported treatment satisfaction assessed using the Visual Analogue Scale (VAS; 0 = not satisfied at all, 10 = completely satisfied).
Time frame: 12 months after surgery
Patient-reported willingness to choose the same treatment again assessed using a dichotomous (yes/no) question.
Time frame: 12 months after surgery
Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question.
Contact information is provided by the study sponsor or research team.
Bartłomiej Górski
CONTACT
Magdalena Latkowska - Wiśniewska
CONTACT
Medical University of Warsaw
Other
Impact of Root Surface Conditioning With Erythritol Air Polishing Versus Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft: A Randomized Clinical Trial
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