Palatal Tissue vs Collagen Matrix for Receding Gums
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine whether the patient's own gum tissue or a pig-derived collagen matrix (Zderm™) works better for gum graft surgery. Both options assist individuals with thin gums around teeth or dental implants. Participants will undergo random assignment to receive surgery with either their own tissue or the collagen matrix. Ideal candidates for this trial include those with dental implants needing gum augmentation and who smoke fewer than 10 cigarettes a day. As an unphased trial, this study allows participants to contribute to important research that could enhance future dental treatments.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research from previous studies shows that using a collagen matrix for gum treatment is generally safe. For example, 8 out of 10 patients experienced complete healing. Another study found that these collagen materials help gums heal without causing harmful effects or complications. Derived from pig tissue, this collagen matrix has been used in gum surgeries for a long time. It offers a safe alternative to using a person's own gum tissue. So far, patients have tolerated the collagen matrix well, with no reports of toxicity or serious side effects.12345
Why are researchers excited about this trial?
Unlike the standard treatment for receding gums, which typically involves using a patient's own tissue from the palate, Zderm™ offers a novel approach by utilizing a porcine collagen matrix. This innovative material aims to simplify the procedure by eliminating the need for a second surgical site to harvest tissue, potentially reducing patient discomfort and recovery time. Researchers are excited about Zderm™ because it could offer a less invasive alternative with similar or improved outcomes in gum tissue augmentation.
What evidence suggests that this trial's treatments could be effective for receding gums?
This trial will compare the effectiveness of a collagen matrix, such as Zderm™, with traditional palatal grafts for treating receding gums. Studies have shown that a collagen matrix can reduce the gap between the gum line and the tooth root by an average of 3.39 mm, covering 43% to 56% of the exposed root. Most patients heal completely within two weeks and experience less pain compared to traditional methods using tissue from their own palate. Additionally, research suggests that the collagen matrix provides lasting results over several years, making it a promising option for treating gum recession. Participants in this trial will join either the collagen matrix group or the palatal graft group to evaluate these outcomes.12346
Who Is on the Research Team?
Brian L Mealey, DDS, MS
Principal Investigator
The University of Texas Health Science Center at San Antonio
Are You a Good Fit for This Trial?
This trial is for people with receding gums or thin gum tissue around teeth or dental implants who need gum graft surgery. Participants must be able to undergo dental procedures and attend regular follow-up visits.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo gum tissue graft surgery using either autograft palatal donor tissue or xenograft collagen matrix from porcine Achilles tendon
Follow-up
Participants are monitored for changes in graft dimensions, color match, pain, and analgesic consumption
What Are the Treatments Tested in This Trial?
Interventions
- Zderm™
Trial Overview
The study compares two types of gum grafts: one uses the patient's own palate tissue, and the other uses a collagen matrix made from pig tendon (Zderm). Patients are randomly assigned to either group during routine dental appointments.
How Is the Trial Designed?
2
Treatment groups
Active Control
The recipient site to which the Zderm™ material will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT.
The recipient site to which the palatal autogenous donor tissue will be placed will be prepared with a standard of care split thickness tissue flap at the site which needs augmentation of the KT. The harvested tissue will be trimmed to the required size and shape with surgical scissors as indicated by the number of tooth/implant sites to be augmented
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Who Is Running the Clinical Trial?
The University of Texas Health Science Center at San Antonio
Lead Sponsor
Citations
Current Insight of Collagen Biomatrix for Gingival Recession
-PADM shows complete healing with absence of adverse effects in five sites with -PADM shows an increase in soft tissue thickness and height, dense
porcine collagen matrix with and without enamel matrix - DTIC
Collagen matrices used for gingival recession coverage result in similar outcomes to those achieved with connective tissue autografts.
The Use of Collagen Matrix in the Treatment of Gingival ...
On average, the RD decreased by 3.39 mm, and the RW by 3.87 mm. The partial root coverage was 43.48%, and the total root coverage was 56.52%.
Collagen Matrix After Gum Grafting for Gum Recession
In one study, 8 out of 10 patients experienced complete healing within two weeks, indicating that the collagen matrix is well-tolerated.
Treating receding gums
Using a collagen matrix instead of a graft from your palate is much less painful and eliminates the need to create a second surgical site.
New trends in the treatment of gingival recessions with ...
is an acellular collagen matrix that offers a safe alternative to autologous soft tissue transplants. in the treatment of gingival recessions. ...
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