The influence of tension on wound closure on volume gain in the reconstruction of gingival tissue: a prospective cohort study
Descrizione riassuntiva dello studio
Soft tissue deficits can be reconstructed using substitute materials. These substitute materials are placed in a previously prepared tissue pocket and the adjacent gingival tissue is sutured over it. The amount of substitute material used and the tension on this wound closure through sutures are very individual and vary depending on the situation. We believe that too much tension on the wound closure leads to a poorer volume gain and increases the risk of wound healing complications. Ideally, the surgery should be performed in such a way that the adjacent tissue is well mobilized to create as much space as possible for the substitute material. Subsequently, an adjusted amount of substitute material must be introduced to maximize volume without generating excessive tension on the wound closure. It is a complex issue and several factors are responsible for success. The aim of this study is to explore the relationships between these factors.
(BASEC)
Intervento studiato
Measurement of volume gain and soft tissue tension at wound closure
(BASEC)
Malattie studiate
Single tooth implant or bridge in the upper jaw with a soft tissue deficit.
(BASEC)
- Single tooth implant or bridge in the upper jaw with soft tissue deficit - Adjacent teeth present (BASEC)
Criteri di esclusione
- Active periodontitis - Smoking more than 10 cigarettes per day - Allergy to collagen-based materials (BASEC)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
University of Zurich Center of Dental Medicine Clinic of Reconstructive Dentistry
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Daniel Thoma
+41 44 634 04 04
research.rzm@clutterzzm.uzh.chUniversity of Zurich, Center of Dental Medicine Clinic of Reconstructive Dentistry
(BASEC)
Informazioni generali
Universitt Zrich, Zentrum fr Zahnmedizin, Klinik fr Rekonstruktive Zahnmedizin
+41 44 634 04 04
research.rzm@clutterzzm.uzh.ch(ICTRP)
Informazioni scientifiche
Universit?t Z?rich, Zentrum f?r Zahnmedizin, Klinik f?r Rekonstruktive Zahnmedizin
+41 44 634 04 04
research.rzm@clutterzzm.uzh.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
01.09.2021
(BASEC)
ID di studio ICTRP
DRKS00025804 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study (BASEC)
Titolo accademico
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension') - Flap tension (ICTRP)
Titolo pubblico
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension') (ICTRP)
Malattie studiate
Soft-tissue dehiscence in the upper jaw (single tooth implant or pontic) (ICTRP)
Intervento studiato
Group 1: Soft-tissue augmentation (ICTRP)
Tipo di studio
interventional (ICTRP)
Disegno dello studio
Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment (ICTRP)
Criteri di inclusione/esclusione
Inclusion criteria: Maxillary single implant sites with two neighboring teeth or pontic sites with two neighboring teeth aimed for reconstruction with an FDP or an RBB
GBR procedures and implant surgeries at least 3 months ago (if performed)
Biologic or esthetic indication for a soft tissue augmentation
Clinical attachment level >80% at neighboring teeth (ICTRP)
Exclusion criteria: Active periodontitis (PD =5mm)
Smoking of >10 cigarettes per day
General contraindications for dental and/or surgical treatment
Uncontrolled diabetes
Pregnancy or breast feeding
Disease affecting connective tissue metabolism (e.g. collagenases)
Allergy to collagen-based substitutes
Allergy against local anesthetics
Endpoint primari e secondari
Volumetric change from Baseline (visit 1) to 8 weeks of healing following soft tissue augmentation (visit 4), based on intraoral scans (STL-files) (ICTRP)
� Initial soft tissue thickness (CBCT scan)
� Flap tension at wound closure (measured with a high precision advanced force strain gauge)
� Volume gain following surgery (Superimposition of STL files)
� Flap thickness at surgery (with caliper)
� Surgery time from first incision to last suture
� Mucosal scarring index at 1 week following surgery (ICTRP)
Data di registrazione
09.09.2021 (ICTRP)
Inclusione del primo partecipante
11.03.2022 (ICTRP)
Sponsor secondari
non disponibile
Contatti aggiuntivi
Stefan Bienz, stefan.bienz@zzm.uzh.ch, +41 44 634 04 04, Universitt Zrich, Zentrum fr Zahnmedizin, Klinik fr Rekonstruktive Zahnmedizin (ICTRP)
ID secondari
2021-01467 (ICTRP)
Risultati-Dati individuali dei partecipanti
No (ICTRP)
Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00025804 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile