NovoMatrix in Gingival Recession Coverage: Case Series

NCT06409468 | Recruiting

• 1 other identifier: Novomatrix
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Gingival Recession, Generalized

Outcome Measures

Primary Outcomes (1)

• Histology

  histologically evaluate the quality of newly formed soft tissues 6 months following gingival recession coverage utilizing NovoMatrix.

  6 months

Secondary Outcomes (8)

• Postoperative Blood Perfusion changes

  Day 0, 1, 4, 7, 10, 14, Month 1, 3, 6

• Recession depth

  Baseline, 1, 3, 6 months and 1 year

• Recession width

  Baseline, 1, 3, 6 months and 1 year

• Papilla-Contact point distance

  Baseline, 1, 3, 6 months and 1 year

• Papilla width

  Baseline, 1, 3, 6 months and 1 year

Study Arms (1)

Coronally Advanced Tunnel with NovoMatrix

EXPERIMENTAL

Gingival Augmentation Procedure using NovoMatrix + Coronally Advanced Tunnel

Procedure: Subperiostal tunnel in conjunction with Novomatrix

Interventions

Subperiostal tunnel in conjunction with Novomatrix PROCEDURE

An intrasulcular incision on the tooth with recession and on each adjacent tooth. Subperiosteal pouches dissected apically for about 6-8 mm facial to the 3 teeth and connected by extension of the subperiosteal dissection into the interdental areas to create a tunnel. NovoMatrix trimmed to a vertical dimension of 7-8 mm and a horizontal length to completely over the exposed roots and extend laterally to the root line angles of the adjacent teeth. The graft inserted into the tunnel and aligned. Both the overlying tissue and graft positioned 1mm coronally to the level of the cementoenamel junction and secured with a 6-0 resorbable sling suture.

Coronally Advanced Tunnel with NovoMatrix

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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 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.

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University, Faculty of Dentistry

Budapest, 1088, Hungary

RECRUITING

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Study Officials

• Péter Windisch, Profesor

  Semmelweis University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bálint Molnár, DMD

CONTACT

0613185222; molbal81@gmail.com

Andrea Dobos, DMD

CONTACT

06309532140; andobos@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Case series

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 10, 2024
• Study Start: May 5, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)