NCT07403006

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
13mo left

Started Mar 2026

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress16%
Mar 2026Jul 2027

First Submitted

Initial submission to the registry

January 21, 2026

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

March 9, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

March 10, 2026

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

January 21, 2026

Last Update Submit

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

EXPERIMENTAL

Sites with gingival recessions treated with root surface preparation using erythritol air-polishing prior to modified tunnel technique with subepithelial connective tissue graft.

Procedure: Erythritol Air-Polishing

Manual Root Instrumentation

ACTIVE COMPARATOR

Sites with gingival recessions treated with root surface preparation using manual Gracey curettes prior to modified tunnel technique with subepithelial connective tissue graft.

Procedure: Manual Root Instrumentation

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.

Erythritol Air-Polishing

Mechanical root surface preparation performed using manual Gracey curettes before root coverage surgery with a modified tunnel technique and subepithelial connective tissue graft.

Manual Root Instrumentation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Bartłomiej Górski

    Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

    STUDY CHAIR

Central Study Contacts

Magdalena Latkowska - Wiśniewska

CONTACT

Bartłomiej Górski

CONTACT

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

Locations