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Effekten av rotflatebehandling med erythritol luftpolering og håndinstrumentering på dekning av tannkjøttsrecessjon ved bruk av den modifiserte tunnelteknikken og subepitelialt bindevevsgraft.

1. oktober 2026 oppdatert av: Medical University of Warsaw

Effekten av rotflatebehandling med erythritol-luftpolering versus håndinstrumentering på dekning av tannkjøttsrecessjon ved bruk av den modifiserte tunnelteknikken og subepitelial bindevevsgraft: En randomisert klinisk studie

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.

Studieoversikt

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år til 60 år (Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

9. mars 2026

Primær fullføring (Antatt)

1. juni 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

21. januar 2026

Først innsendt som oppfylte QC-kriteriene

3. februar 2026

Først lagt ut (Faktiske)

11. februar 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. oktober 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. oktober 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • WUM.Perio.06

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Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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