Autologous Blood Membrane Technique for Gum Recession

Overseen By Ann-Marie Jacobson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Smoking, Pregnancy, Non-compliance, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 visits over 5 years

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks a new method to treat gum recession by using a patient's own blood to create a special membrane. The goal is to provide an alternative to taking tissue from the roof of the mouth or using donor tissue. Participants will undergo two types of gum grafting procedures (also known as soft tissue grafting) to evaluate the effectiveness of the new method. Individuals with gum recession needing treatment for two or more areas without existing gum restoration may be suitable for this trial. As an unphased study, this trial allows participants to contribute to innovative research that could lead to new treatment options for gum recession.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Autologous Blood Membrane Technique is safe for correcting gum recession?

Research has shown that using a patient's own tissue for gum grafting reliably treats gum recession. This method involves taking tissue from the roof of the mouth and placing it where needed. Studies have found this technique to be generally safe and predictable, with many patients experiencing good results.

Side effects are rare, with most people feeling only mild discomfort after the procedure, similar to a routine dental visit. Some temporary swelling and soreness at the graft site are common, but these usually subside within a few weeks.

Overall, using a patient's own tissue in gum grafting is well-tolerated and considered the best method for treating gum recession. It avoids the need for tissue from other sources, reducing the risk of rejection or complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Autologous Blood Membrane Technique for gum recession because it explores using the body's own resources to heal itself. Unlike traditional soft tissue grafting methods, which typically involve taking tissue from the roof of the mouth, this technique utilizes platelet-rich fibrin (PRF) to promote healing and tissue regeneration. PRF is derived from the patient's own blood, reducing the risk of rejection and potentially speeding up recovery. By experimenting with this innovative approach, researchers hope to find a less invasive and more efficient solution for treating gum recession.

What evidence suggests that the Autologous Blood Membrane Technique is effective for gum recession?

Research has shown that soft tissue grafting effectively treats gum recession. Studies have found that using tissue from the roof of the mouth can successfully cover exposed tooth roots. This method reduces tooth sensitivity and improves the appearance of gums. In this trial, participants will receive the CTG procedure on one side, which involves using tissue from the roof of the mouth. On the other side, they will receive the PRF procedure, which uses a membrane made from their own blood, avoiding the need for a second surgical site. This aspect appeals to many patients. Overall, both methods are considered reliable and effective for addressing gum recession. ^{1 2 6 7 8}

Who Is on the Research Team?

Tannaz Shapurian, DMD, MSc

Principal Investigator

Tufts University School of Dental Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who need treatment for gum recession at two or more sites but don't want a second surgical site or donor tissue. Smokers, pregnant individuals, those not consenting to recommended therapy, and anyone unable to follow up are excluded.

Inclusion Criteria

No class V restoration present

I need gum treatment for root coverage at 2 or more sites.

Class A +/-

Exclusion Criteria

Patients who will not be able to comply with follow-up protocols

Patients who do not consent to recommended therapy

Patients who smoke

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CTG procedure on one side and PRF procedure on the other to correct gum recession

12 visits over 5 years

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment using intraoral scanner to establish volume stability

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Soft Tissue Grafting

Trial Overview The study tests the use of patients' own blood prepared as a membrane versus traditional grafting from the roof of the mouth for treating gum recession. It's a split-mouth design, meaning each patient receives both treatments in different areas.

How Is the Trial Designed?

Group I: All Participants Experimental Treatment 1 Intervention

Participants will receive the CTG procedure on one side and the PRF procedure on the other. Both are standard of care soft tissue grafting methods and a split mouth design is standard of care.

Soft Tissue Grafting is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Soft Tissue Grafting for:

• Gum recession
• Periodontal defects
• Oral soft tissue augmentation

Approved in European Union as Soft Tissue Grafting for:

• Gum recession
• Periodontal defects
• Oral soft tissue augmentation

Approved in Canada as Soft Tissue Grafting for:

• Gum recession
• Periodontal defects
• Oral soft tissue augmentation

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Published Research Related to This Trial

The technique of using coronally advanced gingival flaps combined with rhPDGF-BB-saturated graft material shows significant effectiveness in achieving root coverage and improving the aesthetic appearance of recession defects in periodontal treatment.

This method not only provides excellent cosmetic results but also promotes periodontal regeneration, including the potential for new cementum, periodontal ligament, and alveolar bone formation, which is a notable advantage over traditional repair techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative Treatment for Recession Defects Using Purified Human Platelet-Derived Growth Factor-BB, Particulate Grafts, and Coronally Repositioned Flaps. Ganeles, J., Pette, GA.[2020]

In a study involving 20 teeth with gingival recession, both surgical techniques (guided tissue regeneration and connective tissue autotransplants) significantly reduced the vertical depth of recession, indicating their efficacy in treating this condition.

The connective tissue autotransplant technique showed superior results, achieving a 90% reduction in recession depth compared to 63.5% with guided tissue regeneration, highlighting its effectiveness for periodontal regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Therapeutic efficacy of guided tissue regeneration and connective tissue autotransplants with periosteum in the management of gingival recession]. Jovicić, B., Lazić, Z., Nedidć, M.[2019]

Guided tissue regeneration (GTR) using resorbable collagen membranes is an effective alternative to traditional soft tissue grafts for treating gingival recession, as it eliminates the need for a second surgery to harvest donor tissue.

The collagen membranes not only serve as effective barriers to promote healing but also enhance the thickness of the gingiva and may aid in early wound healing due to their platelet-aggregating properties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of gingival recession with collagen membranes. Peacock, ME., Cuenin, MF., Mott, DA., et al.[2006]

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]

A new bioabsorbable bilayer collagen membrane has been successfully used to treat gingival recession, offering a less invasive alternative to traditional soft tissue grafts by eliminating the need for donor site surgery.

This membrane adapts well to bone and tooth surfaces, stabilizing without sutures, and has shown effectiveness in both guided bone regeneration and periodontal defect treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gingival recession treatment using a bilayer collagen membrane. Burns, WT., Peacock, ME., Cuenin, MF., et al.[2006]

A case report highlights a rare complication of an arterio-venous shunt that occurred after the removal of palatal mucosa for a soft tissue graft in periodontal treatment.

The complication was successfully managed through surgical excision, and the healing process following the procedure was uneventful, indicating that while complications can occur, they can often be effectively treated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unusual wound healing following removal of donor tissue for soft tissue graft. Adcock, JE., Spence, D.[2004]

The use of autologous blood products (ABPs) in mucogingival surgery showed no adverse events and led to satisfactory treatment outcomes, suggesting they are safe and effective adjuncts to traditional grafting procedures.

ABPs may particularly benefit patients with local or systemic complications, enhancing the predictability of clinical and esthetic results in mucogingival treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of mucogingival therapies utilizing adjunctive autologous blood products. Geisinger, ML., Kaur, M., Abou Arraj, RV., et al.[2023]

Mucogingival plastic surgery aims to achieve complete root coverage and aesthetic blending of treated and untreated tissues, addressing the growing demand for cosmetic dental procedures.

While the connective tissue graft is often seen as the best option for treating gingival recession, the choice of surgical technique should be based on a careful evaluation of individual patient and defect characteristics, as all root coverage methods can be effective under real-world conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decision Making in Gingival Recession Treatment: Scientific Evidence and Clinical Experience. Rasperini, G., Acunzo, R., Limiroli, E.[2020]

Minimally invasive coronally advanced flap-based surgical techniques for treating gingival recession may offer improved esthetic results and reduced patient discomfort compared to traditional methods that use autogenous tissue, which can cause more morbidity.

This review evaluates five specific minimally invasive techniques, highlighting their clinical applications and potential benefits in achieving effective root coverage with less impact on patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimally Invasive Coronally Advanced Flap Techniques for Correction of Gingival Recession Defects: A Review. Duffy, JM., Latimer, JM., Fried, RM., et al.[2023]

In a study of 18 patients with gingival recession, the tunnel technique combined with subepithelial connective tissue graft (TUN+CTG) showed significantly better clinical outcomes than the coronally advanced flap with enamel matrix derivative (CAF+EMD) after 5 years, with 50% of TUN+CTG sites achieving complete root coverage compared to 0% for CAF+EMD.

The TUN+CTG technique also resulted in greater recession reduction and thicker marginal soft tissue, indicating improved aesthetic outcomes, although there were no significant differences in patient-centered satisfaction between the two techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tunnel technique with connective tissue graft versus coronally advanced flap with enamel matrix derivate for root coverage: 5-year results of an RCT using 3D digital measurement technology for volumetric comparison of soft tissue changes. Zuhr, O., Akakpo, D., Eickholz, P., et al.[2021]

In a study of 14 patients with gingival recession around implants, the use of guided bone regeneration (GBR) with a resorbable membrane and allograft significantly improved both hard and soft tissue dimensions in the anterior maxilla after approximately one year.

Postoperative measurements showed significant increases in crestal bone thickness (1.84 mm) and mid-implant buccal bone thickness (2.07 mm), along with improvements in soft tissue thickness, keratinized tissue width, and gingival height, indicating the efficacy of this technique for aesthetic restoration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of Labial Soft Tissue Recession Around Dental Implants in the Esthetic Zone Using Guided Bone Regeneration With Mineralized Allograft: A Retrospective Clinical Case Series. Le, B., Borzabadi-Farahani, A., Nielsen, B.[2022]

Soft tissue grafts are effective in treating various mucogingival deformities, such as ridge deficiencies and lack of keratinized tissue, which can improve both function and aesthetics around teeth and edentulous ridges.

The article details different types of autologous soft tissue grafts, including free and pedicle grafts, and discusses their specific advantages and limitations for various dental conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Soft tissue grafts for the treatment of mucogingival deformities and conditions on edentulous ridges]. Tal, H.[2015]

In a study involving 14 patients with 20 cases of gingival recession, both acellular dermal matrix allograft (ADMA) and subepithelial connective tissue graft (SCTG) showed significant improvements in recession height, recession width, and keratinized gingiva after six months, indicating their effectiveness in treating gingival recession.

The results demonstrated that ADMA is a viable alternative to SCTG, as both techniques produced similar outcomes in root coverage and other clinical parameters, suggesting that ADMA can be used without compromising treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative clinical evaluation of acellular dermal matrix allograft and connective tissue graft for the treatment of gingival recession. Rahmani, ME., Lades, MA.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10222757/

Soft Tissue Grafting Procedures before Restorations in the ... Successful plastic surgery periodontal procedures have been used to correct deficiencies related to gingival recession [11,13]. Connective ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772559624000671

Soft tissue conditioning around teeth: A narrative review This paper will review the gingival dimensions of the periodontium in health and address the prevalence, etiology, and predisposing factors related to defects.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07158541

Comparing TCAF and MTUN With Soft Tissue Grafting for ... This may be clinically relevant because covering gum recession can reduce tooth sensitivity, improve aesthetics and make oral hygiene easier.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10934781/

Soft Tissue Substitutes in Periodontal and Peri-Implant ... Around dental implants, free gingival grafts were deemed more effective than soft tissue substitutes in enhancing keratinized mucosa width.

5. aap.onlinelibrary.wiley.com aap.onlinelibrary.wiley.com/doi/10.1002/JPER.19-0350

Autogenous soft tissue grafting for periodontal and peri ... This state-of-the-art review presents the latest evidence and the current status of autogenous soft tissue grafting for soft tissue augmentation and recession ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK599507/

Overview of Periodontal Surgical Procedures - StatPearls - NCBI The initial treatment of periodontitis is based on non-surgical measures. Scaling and root planing significantly reduce the subgingival microbial burden.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9807852/

Clinical and patient-reported outcomes after recession ... To correct recession defects, a gingival flap in combination with a subepithelial connective tissue graft (SCTG) is generally considered the most predictable ...

8. arlingtondentalma.com arlingtondentalma.com/blog/gum-graft-surgery-success-and-possible-complications

Gum Graft Surgery: Success and Possible Complications Treatment outcome is generally evaluated 4-6 weeks after soft tissue grafting. You need to wait up to 8 weeks or so for tissue maturation ...