The influence of tension on wound closure on volume gain in the reconstruction of gingival tissue: a prospective cohort study
Résumé de l'étude
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)
Intervention étudiée
Measurement of volume gain and soft tissue tension at wound closure
(BASEC)
Maladie en cours d'investigation
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)
Critères d'exclusion
- Active periodontitis - Smoking more than 10 cigarettes per day - Allergy to collagen-based materials (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
University of Zurich Center of Dental Medicine Clinic of Reconstructive Dentistry
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Daniel Thoma
+41 44 634 04 04
research.rzm@clutterzzm.uzh.chUniversity of Zurich, Center of Dental Medicine Clinic of Reconstructive Dentistry
(BASEC)
Informations générales
Universitt Zrich, Zentrum fr Zahnmedizin, Klinik fr Rekonstruktive Zahnmedizin
+41 44 634 04 04
research.rzm@clutterzzm.uzh.ch(ICTRP)
Informations scientifiques
Universit?t Z?rich, Zentrum f?r Zahnmedizin, Klinik f?r Rekonstruktive Zahnmedizin
+41 44 634 04 04
research.rzm@clutterzzm.uzh.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
01.09.2021
(BASEC)
Identifiant de l'essai ICTRP
DRKS00025804 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study (BASEC)
Titre académique
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension') - Flap tension (ICTRP)
Titre public
The influence and relationship of flap tension and graft size on gain of mucosal thickness: A prospective cohort study ('Flap Tension') (ICTRP)
Maladie en cours d'investigation
Soft-tissue dehiscence in the upper jaw (single tooth implant or pontic) (ICTRP)
Intervention étudiée
Group 1: Soft-tissue augmentation (ICTRP)
Type d'essai
interventional (ICTRP)
Plan de l'étude
Allocation: N/A: single arm study; Masking: Open (masking not used); Control: uncontrolled; Assignment: single; Study design purpose: treatment (ICTRP)
Critères d'inclusion/exclusion
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
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
09.09.2021 (ICTRP)
Inclusion du premier participant
11.03.2022 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Stefan Bienz, stefan.bienz@zzm.uzh.ch, +41 44 634 04 04, Universitt Zrich, Zentrum fr Zahnmedizin, Klinik fr Rekonstruktive Zahnmedizin (ICTRP)
ID secondaires
2021-01467 (ICTRP)
Résultats-Données individuelles des participants
No (ICTRP)
Informations complémentaires sur l'essai
http://drks.de/search/en/trial/DRKS00025804 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible