- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07706257
Gingival Unit Graft Versus Free Gingival Graft: 18-Month Digital Color Analysis
15. juli 2026 opdateret af: Sanubar Shakiliyeva, Bezmialem Vakif University
Clinical Outcomes and Digital Color Stability of Gingival Unit Graft Versus Free Gingival Graft: An 18-Month Comparative Digital Photographic Color Analysis Study
The purpose of this retrospective clinical study is to compare the long-term aesthetic integration and clinical outcomes of two periodontal plastic surgery techniques: Gingival Unit Grafting (GUG) and Free Gingival Grafting (FGG).
The study evaluates the effectiveness of these procedures in increasing keratinized tissue width and assesses the color integration of the grafted tissues with the surrounding gingiva over an 18-month follow-up period using objective digital color analysis based on CIE Lab and RGB parameters.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
This single-center retrospective study included patients treated with either Gingival Unit Grafts (GUG) or Free Gingival Grafts (FGG) for the management of Cairo Type 2 and Type 3 gingival recessions between March 2022 and December 2022.
Clinical and photographic records obtained at baseline and during follow-up visits up to 18 months were retrospectively analyzed.
The primary outcome was the evaluation of color integration of the grafted tissues using objective digital color analysis based on CIE Lab and RGB parameters.
Secondary outcomes included changes in keratinized tissue width.
The aim of the study was to compare the long-term aesthetic integration and clinical performance of GUG and FGG and to determine which technique provides superior color matching with the surrounding tissues.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Fatih
-
Istanbul, Fatih, Tyrkiet (Türkiye), 34093
- Bezmialem Vakif University, Faculty of Dentistry
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
The study population consists of adult patients seeking treatment for localized gingival recessions on mandibular incisors at a university faculty of dentistry.
Beskrivelse
Inclusion Criteria:
- Systemically healthy individuals aged between 18 and 65 years
- No systemic diseases contraindicating periodontal surgery
- Not taking medications known to exert adverse effects on periodontal tissues
- Presenting with Cairo Type 2 (RT2) or Type 3 (RT3) localized gingival recessions on mandibular incisors
- Presence of ≤1 mm of attached gingiva resulting in difficulty maintaining plaque control
- Full-mouth plaque and gingival index scores ≤1
- Bleeding on probing (BOP) <10%
- No history of prior soft tissue surgery in the designated area
Exclusion Criteria:
- Individuals who are pregnant or lactating.
- Presenting with gingival recession or prosthetic restorations at the donor site (maxillary premolar palatal region).
- Cases demonstrating caries, abrasions, or restorations on the root surfaces of the related teeth.
- Individuals with known allergies to dental impression materials.
- Periodontal pocket depth greater than 3 mm.
- Tooth malposition.
- Endodontic complications.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Gingival Unit Graft (GUG) Group
Patients who underwent periodontal plastic surgery using Gingival Unit Grafts for keratinized tissue gain
|
Harvesting a gingival unit graft and transplanting it to the recipient area to increase keratinized tissue width and assess long-term aesthetic integration.
|
|
Conventional Free Gingival Graft (FGG) Group
Patients who underwent periodontal plastic surgery using Conventional Free Gingival Grafts for keratinized tissue gain
|
Harvesting a conventional free gingival graft and transplanting it to the recipient area to increase keratinized tissue width and serve as a control group for aesthetic integration.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Aesthetic Integration (Color Evaluation)
Tidsramme: Baseline and 18 months post-surgery
|
Objective assessment of color integration between the grafted tissue and the surrounding gingiva using digital color analysis.
Color parameters were evaluated based on the CIE Lab* color space system and RGB color channels obtained from standardized clinical photographs.
The degree of color matching between grafted and adjacent tissues was assessed over the follow-up period.
|
Baseline and 18 months post-surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Keratinized Tissue Width (KTW)
Tidsramme: Baseline and 18 months post-surgery
|
The clinical measurement of the width of keratinized tissue in millimeters, evaluated from the gingival margin to the mucogingival junction using a standard periodontal probe to determine the amount of tissue gain.
|
Baseline and 18 months post-surgery
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. marts 2022
Primær færdiggørelse (Faktiske)
30. juni 2024
Studieafslutning (Faktiske)
31. december 2024
Datoer for studieregistrering
Først indsendt
11. juli 2026
Først indsendt, der opfyldte QC-kriterier
11. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
15. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- No: 2024/304
Plan for individuelle deltagerdata (IPD)
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