Root coverage using subepithelial connective tissue grafts from different layers of the masticatory mucosa at the hard palate: a randomized controlled trial assessing clinical, volumetric, histomorphometric and patient-centered outcomes
- Conditions
- REZESSIONSDECKUNG
- Registration Number
- DRKS00024587
- Lead Sponsor
- Goethe-Universität Frankfurt | Campus Niederrad Zentrum der Zahn-, Mund- und Kieferheilkunde Carolinum Zahnärztliches Universitäts-Institut gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 14
• Male and female, systemically healthy patients, at least 18 years of age, presenting six adjacent buccal gingival recession defects in the lower jaw (at least one of these with a depth = 2mm) requiring surgical intervention.
• Masticatory mucosa of the palate between canine and first molar has to be 2.5 mm thick
• Patients should be treatment naïve with regard to root coverage procedures. Pre-treatment should include therapy of gingivitis, if necessary, instructions in non-traumatic oral hygiene and reconstruction of the cemento-enamel junction with adhesive dental restorations in case of cervical abrasion, erosion, caries or in case of pre-existing insufficient cervical fillings.
• Periodontal health (no active periodontal disease) including the ability to achieve good oral hygiene and control gingivitis with full-mouth plaque score (FMPS) and full-mouth bleeding score (FMBS) = 25%.
• No medication known to interfere with periodontal tissue health or healing.
• No contraindication for elective periodontal plastic surgery.
• Non-smokers.
• No pregnancy.
• Ability to understand study procedures and to comply with them for the entire duration of the study. Ability and willingness to give written informed consent.
• Persistence of uncorrected gingival trauma from tooth brushing.
• Interdental attachment loss greater than 1mm.
• Presence of severe tooth malpositioning, rotation or extrusion.
• Presence of any kind of indirect dental restoration involving the buccal structures of the cemento-enamel junction.
• Presence of active caries lesions or any evidence of acute or chronic pulpal pathology involving the surrounding periodontal tissues.
• Participation in another clinical trial, inability or unwillingness to give written informed consent or any other non-fulfilment of any of the above-mentioned inclusion criteria.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Digital measurements at baseline, intra-operatively, during initial healing and at 12 months
- Secondary Outcome Measures
Name Time Method Histological and immunohistochemical evaluation