Impact of Root Surface Conditioning With Erythritol Air Polishing and Hand Instrumentation on Recession Coverage Using the Modified Tunnel Technique and Subepithelial Connective Tissue Graft.
1 other identifier
interventional
20
1 country
1
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.
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 Mar 2026
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
January 21, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
March 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
March 10, 2026
August 1, 2025
1.2 years
January 21, 2026
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Root Coverage (MRC, %)
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.
6 months and 12 months post-surgery
Secondary Outcomes (19)
Gingival recession height (GRH, mm)
baseline, 6 months, and 12 months post-surgery
Gingival recession width (RW, mm)
baseline, 6 months, and 12 months post-surgery
Clinical Attachment Level (CAL, mm)
Baseline; 6 and 12 months post-surgery
Probing Pocket Depth (PPD, mm)
baseline, 6 months, and 12 months post-surgery
Gingival Thickness (GT, mm)
baseline, 6 months, and 12 months post-surgery
- +14 more secondary outcomes
Other Outcomes (4)
Procedure-related stress (VAS, 0-10)
Baseline (day of surgery, pre-anesthesia)
Treatment satisfaction (VAS, 0-10)
12 months after surgery
Willingness to choose the treatment again (yes/no)
12 months after surgery
- +1 more other outcomes
Study Arms (2)
Erythritol Air-Polishing
EXPERIMENTALSites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft.
Manual Root Instrumentation
ACTIVE COMPARATORSites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Warsaw, Mazowsze, 00-246, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Bartłomiej Górski
Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2026
First Posted
February 11, 2026
Study Start
March 9, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Last Updated
March 10, 2026
Record last verified: 2025-08