The influence of tension on wound closure on volume gain in the reconstruction of gingival tissue: a prospective cohort study
Zusammenfassung der Studie
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)
Untersuchte Intervention
Measurement of volume gain and soft tissue tension at wound closure
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- Active periodontitis - Smoking more than 10 cigarettes per day - Allergy to collagen-based materials (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
University of Zurich Center of Dental Medicine Clinic of Reconstructive Dentistry
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Daniel Thoma
+41 44 634 04 04
research.rzm@clutterzzm.uzh.chUniversity of Zurich, Center of Dental Medicine Clinic of Reconstructive Dentistry
(BASEC)
Allgemeine Auskünfte
Universitt Zrich, Zentrum fr Zahnmedizin, Klinik fr Rekonstruktive Zahnmedizin
+41 44 634 04 04
research.rzm@clutterzzm.uzh.ch(ICTRP)
Wissenschaftliche Auskünfte
Universit?t Z?rich, Zentrum f?r Zahnmedizin, Klinik f?r Rekonstruktive Zahnmedizin
+41 44 634 04 04
research.rzm@clutterzzm.uzh.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
01.09.2021
(BASEC)
ICTRP Studien-ID
DRKS00025804 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study (BASEC)
Wissenschaftlicher Titel
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension') - Flap tension (ICTRP)
Öffentlicher Titel
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension') (ICTRP)
Untersuchte Krankheit(en)
Soft-tissue dehiscence in the upper jaw (single tooth implant or pontic) (ICTRP)
Untersuchte Intervention
Group 1: Soft-tissue augmentation (ICTRP)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment (ICTRP)
Ein-/Ausschlusskriterien
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
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
09.09.2021 (ICTRP)
Einschluss des ersten Teilnehmers
11.03.2022 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Stefan Bienz, stefan.bienz@zzm.uzh.ch, +41 44 634 04 04, Universitt Zrich, Zentrum fr Zahnmedizin, Klinik fr Rekonstruktive Zahnmedizin (ICTRP)
Sekundäre IDs
2021-01467 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No (ICTRP)
Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00025804 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar