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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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00024587
Enrollment
14
Registered
2021-02-22
Start date
2024-06-11
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

REZESSIONSDECKUNG

Interventions

Group 1: Root coverage by subepithelial connective tissue graft from a more superficial layer of the hard palate Group 2: Root coverage by subepithelial connective tissue graft from a deeper layer of

Sponsors

Goethe-Universität Frankfurt | Campus Niederrad Zentrum der Zahn-, Mund- und Kieferheilkunde Carolinum Zahnärztliches Universitäts-Institut gGmbH
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • 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.

Exclusion criteria

Exclusion criteria: • 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.

Design outcomes

Primary

MeasureTime frame
Digital measurements at baseline, intra-operatively, during initial healing and at 12 months

Secondary

MeasureTime frame
Histological and immunohistochemical evaluation

Countries

Germany

Contacts

Public ContactSophia M. Abraha

Praxis Hürzeler/Zuhr

s.abraha@huerzelerzuhr.com+4917670674713

Outcome results

None listed

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