- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT06366022
Utvärdering av behandling av multipel gingival recession med modifierad koronalt avancerad tunnel med subepitelial bindvävstransplantat beroende på transplantatets placering
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
Tillstånd eller sjukdom: Multipel Gingival recession
Intervention/behandling:
Enhet: Modifierad koronalt avancerad tunnel med bindvävstransplantat placerad med insidan mot fliken Enhet: Modifierad koronalt avancerad tunnel med subepitelial bindvävstransplantat med utsidan mot fliken Fas: Ej tillämpligt
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
MAzowsze
-
Warsaw, MAzowsze, Polen, 00-246
- Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Ålder ≥ 18 år
- Bilaterala flera tandköttsrecessioner i homologa tänder i samma båge.
Exklusions kriterier:
- Plackindex i hela munnen ≥ 20 % (Ainamo & Bay 1975)
- Full-mouth sulcus blödningsindex ≥ 15% (Mühlemann & Son 1971)
- Rökning
- Systemiska sjukdomar med nedsatt läkningspotential av infektionssjukdomar
- Läkemedel som påverkar tandlossning/läkning
- Dräktiga och ammande honor
- Tidigare parodontitkirurgi i området
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / 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.
|
|
Experimentell: 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percent Change in Gingival Recession (Mean Root Coverage, MRC)
Tidsram: Baseline and 6 months after surgery
|
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%.
|
Baseline and 6 months after surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
GR Change (Gingival Recession Height Change) GT Change (Gingival Thickness) KTW Change (Keratinized Tissue Width)
Tidsram: 6 months after surgery
|
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
|
6 months after surgery
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Root Coverage Esthetic Score (RES)
Tidsram: 6 months after surgery
|
RES:The following variables were assessed:
|
6 months after surgery
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Bartłomiej Górski, PhD, Department of Periodontology and Oral Mucosa Diseases, Medical University of Warsaw
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Warsaw.06
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