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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The study aims at comparing two different approaches for soft tissue augmentation at implants lacking keratinized and adherent mucosa width: the free gingival graft (FGG) vs the Buccal Strip Graft in combination with a xenogeneic collagen matrix (BSG + CM)

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.

What data supports the effectiveness of the treatment Buccal Strip Graft with a collagen matrix (bSG + CM) for dental surgery?

Research shows that using a collagen matrix (CM) can effectively increase the width of keratinized tissue around dental implants, similar to the traditional free gingival graft (FGG). Although FGG results in more tissue gain, CM offers benefits like reduced surgery time and less postoperative bleeding, making it a viable alternative. ^{1 2 3 4 5}

Is the Buccal Graft + Collagen Matrix safe for dental surgery?

Research comparing collagen matrices like Mucograft to traditional free gingival grafts suggests they are generally safe for use in dental procedures. These studies have shown that collagen matrices can effectively increase tissue around teeth and implants without significant safety concerns. ^{1 2 4 6 7}

How does the Buccal Graft + Collagen Matrix treatment differ from other dental surgery treatments?

The Buccal Graft + Collagen Matrix treatment is unique because it uses a collagen matrix instead of harvesting tissue from another part of the mouth, which reduces surgery time and postoperative bleeding. This approach also provides a more natural appearance of the augmented tissue compared to the traditional Free Gingival Graft method. ^{1 2 4 5 8}

Research Team

Lorenzo Tavelli, DDS, MS, PhD

Principal Investigator

Harvard School of Dental Medicine, Boston, USA

Eligibility Criteria

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.

The patient must be able to perform good oral hygiene

Implants diagnosed as healthy (Berglundh et al. 2018)

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Vestibuloplasty: porcine collagen matrix versus free gingival graft: a clinical and histologic study. [2015]

2. Iran 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. [2022]

3. United States 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. [2022]

4. United States 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. [2022]

5. China pubmed.ncbi.nlm.nih.gov

[Short-term clinical efficacy of a collagen matrix and free gingival graft in augmenting keratinized mucosa around dental implants]. [2019]

6. Brazil pubmed.ncbi.nlm.nih.gov

Non-cross-linked collagen type I/III materials enhance cell proliferation: in vitro and in vivo evidence. [2021]

7. Korea (South) 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Keratinized mucosa augmentation guided by double xenogeneic collagen matrix membranes around implants in the posterior mandible: A case report. [2022]