Buccal Graft + Collagen Matrix vs. Free Gingival Graft for Dental Surgery

(FGGvsBSG+CM Trial)

Overseen By Ning Yu, DDS, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard Medical School (HMS and HSDM)

Disqualifiers: Diabetes, HIV, Cancer, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods for improving gum tissue around dental implants. One method uses a traditional gum graft from the roof of the mouth, while the other combines a graft from the inside of the cheek with a collagen matrix, a type of protein support. The researchers aim to determine which method more effectively increases gum tissue thickness. Individuals with dental implants and less than 2 mm of attached gum tissue, who can maintain good oral hygiene, might be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative dental research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, it does require participants to be systemically healthy, which might imply that certain medications affecting systemic health could be a concern. It's best to discuss your specific medications with the trial coordinators.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using a Buccal Strip Graft with a collagen matrix (bSG + CM) is generally safe for dental procedures. Studies comparing collagen matrices to traditional gum grafts indicate they are well-tolerated. No major reports of negative effects have emerged from their use. The collagen matrix used in these studies, such as Mucograft® Seal, is specifically designed to aid soft tissue healing and has been successfully used in similar dental treatments. This suggests that the bSG + CM method should be safe for participants in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the Buccal Strip Graft with a collagen matrix (bSG + CM) because it introduces a new approach to dental surgery. Unlike the conventional Free Gingival Graft (FGG), which involves harvesting tissue from the palate, the bSG + CM uses a buccal strip graft from the inner cheek, combined with a collagen matrix. This method is potentially less invasive and may offer better healing, as it minimizes the need for a second surgical site. Additionally, the collagen matrix could enhance tissue integration and stability at the implant site, potentially leading to improved outcomes.

What evidence suggests that this trial's treatments could be effective for dental surgery?

This trial will compare the effectiveness of two dental surgery methods: the Buccal Strip Graft with a collagen matrix (bSG + CM) and the traditional Free Gingival Graft (FGG). Research has shown that the Buccal Strip Graft with a collagen matrix looks promising. Studies have found that this method significantly increases the width of firmly attached gum tissue, with an average increase of 8±1.7 mm. In contrast, the traditional Free Gingival Graft increased the width by only 4.1±0.7 mm. This suggests that the bSG + CM method might be more effective in improving gum tissue around dental implants. The collagen matrix acts as a support structure, aiding new tissue growth and stabilizing the area, which can lead to better long-term results for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Lorenzo Tavelli, DDS, MS, PhD

Principal Investigator

Harvard School of Dental Medicine, Boston, USA

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are healthy both in their gums and overall health, with good oral hygiene. They must have at least one dental implant needing more gum tissue around it and enough healthy gum on other teeth to provide graft material.

Inclusion Criteria

I have a dental implant with gums that are not firm or attached properly.

Full-mouth plaque score and full-mouth bleeding ≤ 20% (measured at four sites per tooth)

I have healthy gums around at least two teeth not next to my dental implant.

Exclusion Criteria

I have a condition like diabetes or HIV that could affect wound healing.

I have untreated gum disease around my dental implant.

Patients pregnant or attempting to get pregnant (self-reported)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a free gingival graft or a buccal strip gingival graft with a collagen matrix for soft tissue augmentation at implant sites

1 day

1 visit (in-person)

Follow-up

Participants are monitored for clinical, volumetric, ultrasonographic, and patient-reported outcomes related to soft tissue augmentation

12 months

Multiple visits at 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Buccal Strip Graft with a collagen matrix (bSG + CM)
• Conventional Free Gingival Graft Approach (FGG)

Trial Overview The study compares two methods of increasing the amount of tough skin-like tissue around dental implants: a traditional free gingival graft (FGG) versus a buccal strip graft combined with a collagen matrix (BSG + CM).

How Is the Trial Designed?

Group I: Buccal Strip Graft + Collagen matrix (bSG + CM) Experimental Treatment 1 Intervention

Strip graft obtained from the buccal mucosa of a site showing abundant keratinized gingiva, combined with a collagen matrix. The bSG + CM graft is stabilized/sutured to the recipient site (implant).

Group II: Free gingival graft (FGG) Active Control 1 Intervention

Conventional free gingival graft, involving the harvesting of an epithelialized graft from the hard palate, which is then stabilized/sutured to the recipient site (implant).

Buccal Strip Graft with a collagen matrix (bSG + CM) is already approved in European Union, Switzerland, United States for the following indications:

Approved in European Union as Geistlich Mucograft for:

• Soft tissue regeneration
• Keratinized tissue gain
• Recession coverage

Approved in Switzerland as Geistlich Mucograft for:

• Soft tissue regeneration
• Keratinized tissue gain
• Recession coverage

Approved in United States as Geistlich Mucograft for:

• Soft tissue regeneration
• Keratinized tissue gain

Who Is Running the Clinical Trial?

Harvard Medical School (HMS and HSDM)

Lead Sponsor

Trials

208

Recruited

1,421,000+

Osteology Foundation

Collaborator

Trials

12

Recruited

550+

Published Research Related to This Trial

In a study involving 20 patients, a new collagen matrix (CM) was found to be as effective as the traditional free connective tissue graft (CTG) in increasing the width of keratinized tissue after 6 months, with both methods achieving similar results.

The use of the CM resulted in significantly lower patient morbidity, including less pain and reduced surgery time, making it a preferable option for patients needing this type of dental procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new collagen matrix (Mucograft prototype) to enhance the width of keratinized tissue in patients with fixed prosthetic restorations: a randomized prospective clinical trial. Sanz, M., Lorenzo, R., Aranda, JJ., et al.[2022]

In a study involving 14 patients, both porcine collagen matrix (CM) and free gingival grafts (FGG) effectively increased the width of keratinized mucosa around dental implants, showing similar healing outcomes.

The CM group had significantly shorter operation times compared to the FGG group, suggesting that CM could be a more efficient alternative for augmenting keratinized mucosa without the need for harvesting tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibuloplasty: porcine collagen matrix versus free gingival graft: a clinical and histologic study. Schmitt, CM., Tudor, C., Kiener, K., et al.[2015]

The mucograft collagen matrix (CM) significantly increased keratinized tissue around teeth (8±1.7 mm) compared to the free gingival graft (FGG) (4.1±0.7 mm) after 6 months, indicating its efficacy in enhancing gum tissue.

Patients receiving CM reported less pain, shorter surgical time, and better aesthetic outcomes compared to those who underwent FGG, suggesting CM is a safer and more efficient alternative for increasing keratinized tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Mucograft Collagen Matrix® versus Free Gingival Graft to Augment Keratinized Tissue around Teeth: A Randomized Controlled Clinical Trial. Rokn, A., Zare, H., Haddadi, P.[2022]

Mucograft® (MG) is significantly thicker than BioGide® (BG), showing three times the thickness in both dry and wet conditions, which may influence its performance as a collagen matrix.

Both MG and BG support cell proliferation and demonstrate similar early tissue integration in vivo, indicating that they can effectively serve as cell occlusive barriers in tissue engineering applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-cross-linked collagen type I/III materials enhance cell proliferation: in vitro and in vivo evidence. Willershausen, I., Barbeck, M., Boehm, N., et al.[2021]

In a study of 19 patients, both collagen matrix (CM) and free gingival graft (FGG) significantly increased keratinized mucosa around dental implants within 3 months, but FGG resulted in greater tissue gain and less shrinkage compared to CM.

Collagen matrix grafts led to reduced surgery time and less postoperative bleeding, making them a less invasive option despite having lower overall keratinized mucosa gain compared to free gingival grafts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Short-term clinical efficacy of a collagen matrix and free gingival graft in augmenting keratinized mucosa around dental implants]. Wang, Q., Meng, HX., Song, WL., et al.[2019]

In a study involving rats with mucogingival defects, both bacterial cellulose matrix (BCM) and human acellular dermal matrix (ADM) seeded with fibroblasts showed healing results comparable to the gold-standard free gingival grafts (FGGs) after 15 days.

Among the engineered grafts, ADM demonstrated the best clinical and histological outcomes, suggesting its potential as an effective treatment option for mucogingival defects in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bacterial cellulose matrix and acellular dermal matrix seeded with fibroblasts grown in platelet-rich plasma supplemented medium, compared to free gingival grafts: a randomized animal study. Prado, AM., Ferreira, CF., Porto, LM., et al.[2023]

The study demonstrates that using a xenogeneic collagen matrix (XCM) membrane technique for keratinized mucosa augmentation is effective, resulting in significant increases in mucosa width and thickness after 2 months of healing in a 66-year-old patient with insufficient peri-implant keratinized mucosa.

This technique avoids the need for a second surgical site, reducing pain and infection risk, making it a safer alternative to traditional free gingival graft methods for patients with inadequate keratinized mucosa around dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keratinized mucosa augmentation guided by double xenogeneic collagen matrix membranes around implants in the posterior mandible: A case report. Han, C., Cai, Q., Li, B., et al.[2022]

In a study involving 60 patients with single tooth gaps, connective tissue graft (CTG) resulted in a greater increase in buccal soft tissue thickness compared to collagen matrix (CMX), with a final increase of 1.15 mm for CTG versus 0.85 mm for CMX.

While CMX reduced surgery time and resulted in less post-operative haematoma, it was associated with more marginal bone loss, deeper pockets, and mid-facial recession compared to CTG, confirming that CTG remains the preferred method for enhancing soft tissue thickness around implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multi-centre randomized controlled trial comparing connective tissue graft with collagen matrix to increase soft tissue thickness at the buccal aspect of single implants: 3-month results. Cosyn, J., Eeckhout, C., Christiaens, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7882206/

Use of Mucograft Collagen Matrix® versus Free Gingival Graft ... This study aimed to evaluate the mucograft collagen matrix (CM) to increase keratinized tissue around teeth compared to free gingival graft (FGG).

2. withpower.com withpower.com/trial/phase-surgery-3-2023-b6489

Buccal Graft + Collagen Matrix vs. Free Gingival ... The mucograft collagen matrix (CM) significantly increased keratinized tissue around teeth (8±1.7 mm) compared to the free gingival graft (FGG) (4.1±0.7 mm) ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5002444/

Use of a Collagen Matrix as a Substitute for Free Mucosal ... Aim of the present study was to evaluate the efficacy of a xenogenic collagen matrix (Geistlich Mucograft®, Geistlich Pharma AG, Wolhusen, CH), ...

4. geistlich.com geistlich.com/dental/products/matrices/mucograft-seal

Geistlich Mucograft® Seal Your circular porcine collagen matrix for the fast, flapless sealing of extraction sockets with an intact buccal wall for predictable soft tissue dimensions.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06261268

Strip Graft w/ Xenogeneic Matrix vs Free Gingival ... The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap ...

6. geistlich-na.com geistlich-na.com/dental-professionals/products/matrices/mucograft

Geistlich Mucograft Geistlich Mucograft® consists of porcine collagen and is specifically designed for soft-tissue regeneration. The matrix is available in three sizes: 15 x 20 mm ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12135576/

Comparing Connective Tissue Grafts and Collagen Matrix in ... The primary outcomes were attached gingiva width (AGW), recession depth (RD), recession width (RW), and mean root coverage% (MRC%). The ...