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Indvirkning af rodoverfladekonditionering med erythritol-luftpolering og håndinstrumentation på recessiondækning ved brug af den modificerede tunneltilgang og subepitelial bindevævsgraft.

1. oktober 2026 opdateret af: Medical University of Warsaw

Effekten af rodoverfladebehandling med erythritol-luftpolering kontra håndinstrumentering på recessiondækning ved brug af den modificerede tunnelteknik og subepithelial bindevævsgraft: Et randomiseret klinisk forsøg

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.

Studieoversigt

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

    • Mazowsze
      • Warsaw, Mazowsze, Polen, 00-246
        • Rekruttering
        • Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Erythritol Air-Polishing

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

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.

Aktiv komparator: Manual Root Instrumentation

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Root Coverage (MRC, %)
Tidsramme: 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.

6 months and 12 months post-surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Gingival recession height (GRH, mm)
Tidsramme: 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.

baseline, 6 months, and 12 months post-surgery
Gingival recession width (RW, mm)
Tidsramme: 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.

baseline, 6 months, and 12 months post-surgery
Clinical Attachment Level (CAL, mm)
Tidsramme: Baseline; 6 and 12 months post-surgery

Distance from the cemento-enamel junction (CEJ) to the bottom of the gingival sulcus.

Baseline; 6 and 12 months post-surgery
Probing Pocket Depth (PPD, mm)
Tidsramme: baseline, 6 months, and 12 months post-surgery

Distance from the gingival margin to the bottom of the gingival sulcus.

baseline, 6 months, and 12 months post-surgery
Gingival Thickness (GT, mm)
Tidsramme: 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.

baseline, 6 months, and 12 months post-surgery
Keratinized tissue width (KTW, mm)
Tidsramme: baseline, 6 months, and 12 months post-surgery

Distance from the gingival margin to the mucogingival junction

baseline, 6 months, and 12 months post-surgery
Complete Root Coverage (CRC, %)
Tidsramme: 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.

6 months and 12 months post-surgery
Gingival Recession Reduction (GR red, mm)
Tidsramme: 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

6 months and 12 months post-surgery
Clinical Attachment Level Gain (CAL Gain, mm)
Tidsramme: 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

6 months and 12 months post-surgery
Keratinized Tissue Width Gain (KTW Gain, mm)
Tidsramme: 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

6 months and 12 months post-surgery
Tooth Sensitivity (SEN, Schiff score)
Tidsramme: 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
Assessed on the day of surgery before administration of anesthesia, and subsequently at 6 and 12 months after surgery.
Root Esthetic Score (RES, score)
Tidsramme: 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.

6 and 12 months after surgery
Discomfort during the procedure (VAS, 0-10)
Tidsramme: 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).

Immediately after completion of the procedure
Pain intensity (VAS scale, 0-10)
Tidsramme: 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).

1, 2, 4, 7, 14 days after procedure
Postoperative swelling (VAS scale, 0-10)
Tidsramme: 1, 2, 4, 7, 14 days after procedure

Patient-reported swelling assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).

1, 2, 4, 7, 14 days after procedure
Tooth sensitivity (VAS, 0-10)
Tidsramme: 1, 2, 4, 7, and 14 days post-procedure

Patient-reported tooth sensitivity assessed using the Visual Analogue Scale (VAS; 0 = none, 10 = maximum).

1, 2, 4, 7, and 14 days post-procedure
Gingival color (VAS, 0-10)
Tidsramme: 6 and 12 months post-surgery

Patient-reported gingival color assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).

6 and 12 months post-surgery
Gingival shape (VAS 0-10)
Tidsramme: 6 and 12 months post-surgery

Patient-reported gingival shape assessed using a single Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent)

6 and 12 months post-surgery
Tooth appearance (VAS, 0-10)
Tidsramme: 6 and 12 months post-surgery

Patient-reported tooth appearance assessed using the Visual Analogue Scale (VAS; 0 = very poor, 10 = excellent).

6 and 12 months post-surgery

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Procedure-related stress (VAS, 0-10)
Tidsramme: Baseline (day of surgery, pre-anesthesia)

Patient-reported procedure-related stress assessed using the Visual Analogue Scale (VAS; 0 = no stress, 10 = extreme stress).

Baseline (day of surgery, pre-anesthesia)
Treatment satisfaction (VAS, 0-10)
Tidsramme: 12 months after surgery

Patient-reported treatment satisfaction assessed using the Visual Analogue Scale (VAS; 0 = not satisfied at all, 10 = completely satisfied).

12 months after surgery
Willingness to choose the treatment again (yes/no)
Tidsramme: 12 months after surgery

Patient-reported willingness to choose the same treatment again assessed using a dichotomous (yes/no) question.

12 months after surgery
Willingness to recommend the treatment (yes/no)
Tidsramme: 12 months after surgery

Patient-reported willingness to recommend the treatment to others assessed using a dichotomous (yes/no) question.

12 months after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Bartłomiej Górski, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw, Warsaw

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

9. marts 2026

Primær færdiggørelse (Anslået)

1. juni 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

21. januar 2026

Først indsendt, der opfyldte QC-kriterier

3. februar 2026

Først opslået (Faktiske)

11. februar 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. oktober 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • WUM.Perio.06

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