- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06366022
Evaluering af behandling af multipel gingival recession ved hjælp af modificeret koronalt avanceret tunnel med subepitelial bindevævstransplantat afhængigt af transplantatets placering
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Tilstand eller sygdom: Multipel Gingival Recession
Intervention/behandling:
Indretning: Modificeret koronalt fremskreden tunnel med bindevævstransplantat placeret med indersiden mod klappen Indretning: Modificeret koronalt fremskreden tunnel med subepitelialt bindevævstransplantat med ydersiden mod flappen Fase: Ikke relevant
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
MAzowsze
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Warsaw, MAzowsze, Polen, 00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inklusionskriterier:
- Alder ≥ 18 år
- Bilaterale flere tandkødsrecesser i homologe tænder i samme bue.
Ekskluderingskriterier:
- Plakindeks i fuld mund ≥ 20 % (Ainamo & Bay 1975)
- Blødningsindeks for fuldmundssulcus ≥ 15 % (Mühlemann & Son 1971)
- Rygning
- Systemiske sygdomme med kompromitteret helbredelsespotentiale af infektionssygdomme
- Lægemidler, der påvirker parodontal sundhed/heling
- Drægtige og ammende hunner
- Tidligere paradentosekirurgi i området
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: The tunnel technique for root coverage with CTG with outer side of the graft
Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study |
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG).
A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions.
The CTG will be inserted into the tunnel and positioned so that the outer side of the graft faces the inner surface of the flap.
The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
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|
Eksperimentel: The tunnel technique for root coverage with CTG with inner side of the graft
Procedure: A modified microsurgical tunnel technique. Initial sulcular incisions with a microsurgical blade are followed by a full-thickness buccal flap preparations till muco-gingival junction using the tunneling knives. Subsequently, the split-thickness preparation is extended into the mucosal tissue to gain sufficient flap mobility. The papillary regions are detached in their buccal aspects with the periosteum. The graft is inserted the /inner outer side into the tunnel and stabilized with absorbable suspensory sutures. The buccal flap is advanced coronally and stabilized with non-absorbable suspensory sutures. 21 participants were enrolled into the study, as it was designed to be a split mouth study. |
Tunnel technique for root coverage with a subepithelial connective tissue graft (CTG).
A split-thickness mucogingival tunnel will be prepared without vertical releasing incisions.
The CTG will be inserted into the tunnel and positioned so that the inner (deep) side of the graft faces the inner surface of the flap (standardized graft orientation).
The graft will be stabilized with sutures, and the flap will be coronally advanced to completely cover the graft.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percent Change in Gingival Recession (Mean Root Coverage, MRC)
Tidsramme: Baseline and 6 months after surgery
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Mean root coverage (MRC) was calculated as the percent change in gingival recession height from baseline to 6 months using the formula: (GR0 - GR6) / GR0 × 100%.
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Baseline and 6 months after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
Tidsramme: 6 months after surgery
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The analyzed metrics were calculated as follows: GR change= GR0-GR6 (after 6 months); ) [millimetre] higher scores mean better outcome GT change = GT6-GT0 (after 6 months); [millimetre] higher scores mean better outcome KTW change = KTW6-KTW0 (after 6 months); [millimetre] higher scores mean better outcome
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6 months after surgery
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Root Coverage Esthetic Score (RES)
Tidsramme: 6 months after surgery
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RES:The following variables were assessed:
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6 months after surgery
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Bartłomiej Górski, PhD, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Warsaw.06
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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