NovoMatrix in Gingival Recession Coverage: Case Series

Recruiting now · Not applicable

Conditions studied: Gingival Recession, Generalized

In brief

Twenty patients seeking treatment for gingival recession coverage, ranging from 20-70 years of age with multiple Miller Class I or II buccal gingival recessions (depth≥3 mm, at least 3 adjacent teeth) will be recruited for this study. Five patients within the study patient pool looking for further orthodontic or restorative treatment that requires removal of one single rooted tooth within the study site of interest will be selected for histological sample removal. All procedures performed in this study will be executed according to established routine protocols, with the exception of block biopsies of one hopeless tooth per patient (total of 5 patients) at 6 months.

Key facts

Study ID

NCT06409468

Run by

Semmelweis University

People needed

20

Starts

2024-05-05

Expected to finish

2025-12-15

Last updated by the study team

2025-04-04

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female, between 20-70 years of age, who request gingival augmentation or recession coverage.
• Subjects who are willing to sign an informed consent, participate and return for follow-up visits.
• Subjects without significant medical history and currently not on medications that might complicate treatment outcomes.
• Subjects demonstrating good oral hygiene (FMPS, FMBS less than 20%).

You may not qualify if…

• Subjects who do not meet all the inclusion criteria or who will not cooperate with the protocol schedule.
• Subjects who received and failed a previously placed autogenous graft.
• Subjects who have significant untreated periodontal disease, caries, infection or chronic inflammation in the oral cavity within two adjacent tooth positions of the clinical trial area.
• Subjects who have used nicotine-containing products within 3 weeks prior to surgery.
• Subjects who are insulin-dependent diabetic or if their Hgb1c levels > 6.5%.
• Subjects who have had a history of malignancy within the past 5 years (except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma).
• Subjects who are nursing or pregnant.
• Subjects who are presently taking medications (except estrogen/progesterone therapy) or those who are undergoing treatment that in known to have an effect on bone turnover.
• Subjects who have diseases that affect bone metabolism (excluding idiopathic osteoporosis).
• Subjects with a history of an autoimmune disease, documented allergy or multiple allergies to any component of the agents used in this study.
• Acutely infected mucogingival defect site.

Where it is running

• Semmelweis University, Faculty of Dentistry — Budapest, Hungary (enrolling)

Full record on ClinicalTrials.gov

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