Using NovoMatrix for treating gum recession

Safety and Efficacy of NovoMatrix in Gingival Recession Coverage /A Pilot Clinical and Histological Case Series/

This study is testing whether a new treatment called NovoMatrix can help people with gum recession improve their gum health and appearance after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 20 Years to 70 Years
• Sex: All
• Sponsor: Semmelweis University (Academic / other)
• Locations: 1 site (Budapest)
• Trial ID: NCT06409468 on ClinicalTrials.gov

What this trial studies

This study involves twenty patients aged 20-70 with multiple Miller Class I or II buccal gingival recessions seeking treatment for gum recession coverage. Participants will undergo surgery using a subperiostal tunnel technique in conjunction with NovoMatrix, following established dental practice guidelines. Five patients will also have a single rooted tooth removed for histological sampling at the six-month mark. The study aims to assess the effectiveness of this approach in improving gum health and aesthetics.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 20-70 with multiple Miller Class I or II gingival recessions who are in good health and maintain good oral hygiene.

Not a fit: Patients with significant untreated periodontal disease, chronic inflammation, or those who have previously failed autogenous grafts may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could enhance gum coverage and improve oral health for patients with gingival recession.

How similar studies have performed: While similar approaches have been explored, this specific use of NovoMatrix in conjunction with the subperiostal tunnel technique is relatively novel.

Eligibility criteria

Inclusion Criteria:

* 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%).

Exclusion Criteria:

* 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 this trial is running

Budapest

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

Study contacts

• Principal investigator: Péter Windisch, Profesor — Semmelweis University
• Study coordinator: Bálint Molnár, DMD

Conditions Gingival Recession, Generalized