Actively Recruiting
Safety and Efficacy of NovoMatrix in Gingival Recession Coverage A Pilot Clinical and Histological Case Series
Led by Semmelweis University · Updated on 2025-04-04
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of NovoMatrix for treating gingival recession, which affects the gums around teeth. The trial will involve patients aged 20 to 70 who have multiple adjacent sites of gum recession classified as Miller Class I or II, with at least 3 teeth affected. This pilot clinical and histological case series aims to evaluate how well NovoMatrix works for gingival augmentation using accepted dental surgery protocols and follow-up assessments. The treatment involves a surgical procedure called a coronally advanced tunnel where NovoMatrix, a graft material, is placed under the gum tissue to cover exposed roots. The surgery includes local anesthesia, creating a tunnel under the gums, inserting the graft, and securing it with sutures. Follow-up care includes cleaning, oral hygiene instructions, and monitoring at multiple time points up to 6 months post-surgery. Additionally, 5 patients who require tooth extraction for orthodontic or restorative reasons will undergo a block biopsy at 6 months to analyze tissue histology. Participants will attend visits for evaluations before surgery and at days 0, 1, 4, 7, 10, 14, and months 1, 3, and 6 afterwards. Various measurements will be taken such as plaque and gingival indexes, probing depths, recession dimensions, and tissue thickness using probes and imaging devices. Blood flow in the gums will also be monitored using laser imaging. Any adverse events will be recorded. The study duration from treatment to biopsy is up to 6 months, with implant placement or other dental restorations planned around 9 months after biopsy.
CONDITIONS
Brief Title
NovoMatrix in Gingival Recession Coverage: Case Series
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, between 20 and 70 years of age, requesting gingival augmentation or recession coverage
- Willing to sign informed consent and attend follow-up visits
- No significant medical history or medications complicating outcomes
- Good oral hygiene with plaque and bleeding scores less than 20%
You will not qualify if you...
- Failure of previously placed autogenous graft
- Untreated periodontal disease, caries, infection, or chronic inflammation near the study site
- Nicotine use within 3 weeks before surgery
- Insulin-dependent diabetes or Hgb1c levels above 6.5%
- History of malignancy within past 5 years except certain skin or cervical cancers
- Nursing or pregnant women
- Medications or treatments affecting bone turnover (except estrogen/progesterone therapy)
- Diseases affecting bone metabolism excluding idiopathic osteoporosis
- Autoimmune diseases or allergies to study agents
- Acutely infected mucogingival defect site
- Non-cooperation or failure to meet inclusion criteria
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants will undergo demographic, medical history, physical examination, and radiographic assessments.
Duration - Surgery lasts approximately 2 hours with recovery and monitoring over 6 months
Participants undergo gingival augmentation surgery involving a subperiosteal tunnel and NovoMatrix graft placement under local anesthesia.
Participants will attend visits on Day 0, 1, 4, 7, 10, 14, and at Months 1, 3, and 6 post-surgery for clinical evaluations and healing monitoring
Duration - Procedure and healing as needed around biopsy time at 6 months post-surgery
Six months after surgery, a block biopsy is taken under local anesthesia, followed by necessary hard and soft tissue grafting at the biopsy site.
1 visit for biopsy and reconstruction procedure
Duration - Up to 9 months following biopsy
Participants are monitored for healing and outcomes with regular assessments; implant placement or alternative dental procedures may occur approximately 9 months after biopsy depending on individual needs.
Follow-up visits continue through 6 months post-surgery; additional visits for implant placement or prosthetic reconstruction as needed
Trial Site Locations
Total: 1 location
1
Semmelweis University, Faculty of Dentistry
Budapest, Hungary, 1088
Actively Recruiting
Research Team
B
Bálint Molnár, DMD
A
Andrea Dobos, DMD
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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