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Wound healing patterns of different collagen based substitutes - a randomized controlled clinical trial assessing wound closure of an experimental, standardized palatal defect

Wound healing patterns of different collagen based substitutes - a randomized controlled clinical trial assessing wound closure of an experimental, standardized palatal defect - palatal wound dressings

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00016874
Enrollment
20
Registered
2020-01-13
Start date
2020-10-25
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open wound at the palate

Interventions

Group 1: Wound closure with Mucograft Seal (Geistlich Pharma AG, Wolhusen, Switzerland) Group 2: Wound closure with Mucoderm (Botiss medical AG, Berlin, Germany) Group 3: Wound closure with Fibrogide

Sponsors

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Male and female participants at least 18 of age • Sufficient space between the first molar and the canine for two 6mm biopsies with at least 3mm in between • Systemically healthy • Good oral hygiene (Plaque index <30%) • Absence of periodontal disease (Probing depth exceeding 4mm) • Willingness to wear a splint to cover the palate during the observation period • Sufficiently restored dentition • Informed Consent as documented by signature

Exclusion criteria

Exclusion criteria: • Previous surgeries at the palate • Uncontrolled diabetes • Smoking of more than 15 cigarettes per day • Self-declared pregnancy or breast feeding at the date of inclusion or intending to become pregnant during the course of the study • Allergies against local anaesthetics • Known or suspected non-compliance, drug or alcohol abuse • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant • Participation in another study with investigational drug within the 30 days preceding and during the present study • Previous enrolment into the current study • Enrolment of the investigator, his/her family members, employees and other dependent persons.

Design outcomes

Primary

MeasureTime frame
The primary outcome is the progression of wound closure as a percentage of the initial defect at day 7.

Secondary

MeasureTime frame
The secondary outcomes are the defect fill compared to the baseline situation by means of a volumetric analysis, patient reported outcome measures for pain by means of a visual analogue scale and a descriptive histology at 16 and 32 days.

Countries

Switzerland

Contacts

Public ContactStefan P. Bienz

Universität Zürich, Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin

stefan.bienz@zzm.uzh.ch0041 44 634 04 04

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026