Actively Recruiting

Phase Not Applicable
Age: 20Years - 70Years
All Genders
Healthy Volunteers
NCT06409468

NovoMatrix in Gingival Recession Coverage: Case Series

Led by Semmelweis University · Updated on 2025-04-04

20

Participants Needed

1

Research Sites

84 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NovoMatrix in Gingival Recession Coverage: Case Series

Who Can Participate

Age: 20Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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%).
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Semmelweis University, Faculty of Dentistry

Budapest, Hungary, 1088

Actively Recruiting

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Research Team

B

Bálint Molnár, DMD

CONTACT

A

Andrea Dobos, DMD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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