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Clinician- vs. Patient-Reported Esthetic Outcomes After Coronally Advanced Flap

3. november 2026 oppdatert av: Ezgi Gürbüz, Kutahya Health Sciences University

Comparison of Clinician- and Patient-Reported Esthetic Outcomes Following Coronally Advanced Flap Procedures for the Treatment of Gingival Recession

This study aims to evaluate the relationship between clinician-assessed esthetic outcomes, measured using the Root Coverage Esthetic Score, and patient-reported esthetic outcomes, recorded on a Visual Analog Scale, at 6 months following the treatment of Cairo Recession Type 1 and Type 2 gingival recessions with a coronally advanced flap, combined with a connective tissue graft where clinically indicated.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

In this prospective clinical study, patients who apply to our clinic due to the esthetic complaint or dentin sensitivity will be included. After initial periodontal treatment, patients who meet the criteria will have a coronally positioned flap applied under local anesthesia. In areas where the keratinized tissue width is 2 mm or more and the keratinized tissue thickness is more than 1 mm, a coronally positioned flap will be applied alone. In areas where the keratinized tissue width is less than 2 mm and/or the keratinized tissue thickness is 1 mm or less, a connective tissue graft will be applied in addition to the coronally positioned flap. Clinician and patient results will be compared in the esthetic evaluations to be performed six months after the surgical procedure.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

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

Studiekontakt

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 og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Systemically healthy individuals
  • Individuals over 18 years of age
  • Individuals who do not smoke and/or consume alcohol
  • Individuals without active periodontitis
  • Individuals with full-mouth plaque and bleeding scores of less than 15%
  • Presence of single or multiple gingival recessions in the maxilla or mandible
  • The affected tooth must be single-rooted
  • Presence of Cairo classification Type 1 or Type 2 gingival recession on the buccal surface of the tooth
  • A recession depth of at least 2 mm

Exclusion Criteria:

  • Individuals with uncontrolled systemic diseases
  • Women who are pregnant or breastfeeding
  • Individuals who smoke and/or consume alcohol
  • Individuals with active periodontitis
  • Cases involving tooth rotation or malposition
  • Individuals currently undergoing orthodontic treatment
  • Gingival recessions associated with teeth that have undergone endodontic treatment or require restorations
  • Teeth with dental caries
  • Gingival recessions with non-carious cervical lesions that have a horizontal depth (step depth) greater than 1 mm

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: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Coronally advanced flap procedure

Coronally advanced flap procedure for Cairo type 1 or 2 gingival recession sites
Fremgangsmåte: Coronally advanced flap with or without connective tissue graft

Patients will have a coronally positioned flap applied under local anesthesia. In areas where the keratinized tissue width is 2 mm or more and the keratinized tissue thickness is more than 1 mm, a coronally positioned flap will be applied alone. In areas where the keratinized tissue width is less than 2 mm and/or the keratinized tissue thickness is 1 mm or less, a connective tissue graft will be applied in addition to the coronally positioned flap.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Root Coverage Esthetic Score
Tidsramme: Post-operative 6th month

The Root Coverage Esthetic Score evaluates five variables 6 months following surgery (gingival margin, marginal tissue contour, soft tissue texture, mucogingival junction alignment, and gingival color).
Post-operative 6th month
Patient-reported esthetic outcome
Tidsramme: Post-operative 6th month

Patient-reported esthetic outcome will be measured by the Visual Analog Scale (0 representing the minimum value, and 100 maximum value).
Post-operative 6th month

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recession depth
Tidsramme: Pre-operative and post-operative 6th month

The distance between gingival margin and cemento-enamel junction
Pre-operative and post-operative 6th month
Keratinized tissue width
Tidsramme: Pre-operative and post-operative 6th month

The distance between gingival margin and mucogingival junction
Pre-operative and post-operative 6th month
Keratinized tissue thickness
Tidsramme: Pre-operative and post-operative 6th month

The thickness measured 1.5 mm apical to the gingival margin
Pre-operative and post-operative 6th month
Vestibular depth
Tidsramme: Pre-operative and post-operative 6th month

The distance between the gingival margin and the greatest concavity at the mucosal fold
Pre-operative and post-operative 6th month
Mean root coverage
Tidsramme: Post-operative 6th month

([Pre-operative Recession Depth - Post-operative Recession Depth] / Pre-operative Recession Depth) × 100
Post-operative 6th month
Linear dimension change
Tidsramme: Post-operative 6th month

The changes in the horizontal plane measured by superimposition of the STL files
Post-operative 6th month

Samarbeidspartnere og etterforskere

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

Sponsor

Kutahya Health Sciences University

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 (Antatt)

30. november 2026

Primær fullføring (Antatt)

30. november 2027

Studiet fullført (Antatt)

30. november 2027

Datoer for studieregistrering

Først innsendt

3. november 2026

Først innsendt som oppfylte QC-kriteriene

3. november 2026

Først lagt ut (Faktiske)

9. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. november 2026

Sist bekreftet

1. oktober 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • KSBU002

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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