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Recruiting NCT07403006

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.

No phase Interventional Gingival Recession

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Erythritol Air-Polishing, Manual Root Instrumentation.
Who it may be relevant to
Registry conditions: Gingival Recession. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

  • Procedure Erythritol 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.
  • Procedure Manual 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.

Primary outcome measures

  • Mean Root Coverage (MRC, %) [Time frame: 6 months and 12 months post-surgery]
Secondary outcome measures (12)
  • Gingival recession height (GRH, mm) [Time frame: baseline, 6 months, and 12 months post-surgery]
  • Gingival recession width (RW, mm) [Time frame: baseline, 6 months, and 12 months post-surgery]
  • Clinical Attachment Level (CAL, mm) [Time frame: Baseline; 6 and 12 months post-surgery]
  • Probing Pocket Depth (PPD, mm) [Time frame: baseline, 6 months, and 12 months post-surgery]
  • Gingival Thickness (GT, mm) [Time frame: baseline, 6 months, and 12 months post-surgery]
  • Keratinized tissue width (KTW, mm) [Time frame: baseline, 6 months, and 12 months post-surgery]
  • Complete Root Coverage (CRC, %) [Time frame: 6 months and 12 months post-surgery]
  • Gingival Recession Reduction (GR red, mm) [Time frame: 6 months and 12 months post-surgery]
  • Clinical Attachment Level Gain (CAL Gain, mm) [Time frame: 6 months and 12 months post-surgery]
  • Keratinized Tissue Width Gain (KTW Gain, mm) [Time frame: 6 months and 12 months post-surgery]
  • Tooth Sensitivity (SEN, Schiff score) [Time frame: Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.]
  • Root Esthetic Score (RES, score) [Time frame: 6 and 12 months after surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Poland · 1 center
  • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsa — Warsaw

Identifiers

NCT: NCT07403006 · WUM.Perio.06

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗