Health TrialsbyHealthPanel

Effectiveness of Meshed Free Gingival Graft for Widening of Keratinized Tissues

ConditionGingiva Atrophy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGöteborg University

About this trial

The overall objective of this project is to evaluate, over a period of 1 year, the outcomes of either conventional free gingival graft (FGG) or mesh-FGG to increase the width of keratinized mucosa (KM) at implant sites.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

≥18 years of age,

systemically healthy,

presence of ≥2 adjacent implants in both sides of the mandibles showing <2 mm of KM on the buccal aspects,

subjects have to present with discomfort from brushing and/or difficulties in maintaining proper home care due to inadequate dimension of KM

Disqualifiers

pregnancy or lactation,

tobacco smoking,

uncontrolled medical condition,

medication that can affect gingival conditions.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Conventional Free Gingival Graft

    Procedure/Surgery

    Implant site with insufficient dimensions of KM will be covered by a conventional free gingival graft.

  • 'Mesh Free Gingival Graft

    Procedure/Surgery

    Implant site with insufficient dimensions of KM will be covered by a expanded meshed free gingival graft.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Free Gingival GraftActive comparator 1 intervention
Group B: Meshed Free Gingival GraftExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes of Keratinized Mucosa width (KMW)

Measured as the distance from the muco-gingival-junction to the occlusal portion of the mucosa

Time frame
up to 1 year

Secondary outcomes

1

Changes of Keratinized Mucosa Thickness (KMT)

measured by a therapeutic probe with a rubber stop

Time frame
up to 1 year
2

Patient Morbidity

Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')

Time frame
up to 2 weeks
3

Patient Satisfaction

Measured with Visual Analogue Scale (VAS), which consists of a 10cm line, with two end points representing 0 ('not satisfied') and 10 ('satisfied as much as it could possibly be')

Time frame
up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Göteborg University

Lead sponsor

Source ClinicalTrials.gov
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