Timing of Gum and Bone Surgery

Overseen By Sarah Startley, DMD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Alabama at Birmingham

Must not be taking: Bisphosphonates, Anti-inflammatories

Disqualifiers: Infectious diseases, Diabetes, Cancer, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This clinical trial aims to compare and evaluate the clinical outcomes between two distinct treatment sequences: free gingival graft surgery preceding guided bone regeneration and guided bone regeneration followed by free gingival graft.

Will I have to stop taking my current medications?

The trial requires that you stop taking medications that affect bone healing, such as bisphosphonates and long-term anti-inflammatory medications.

What data supports the effectiveness of the treatment Free Gingival Graft (FGG) and related procedures?

Research shows that Free Gingival Graft (FGG) is a reliable method to increase the width of keratinized gingiva (the firm, pink gum tissue) and is effective in treating gingival recessions (gum tissue loss). A novel procedure for FGG has been shown to minimize graft shrinkage and improve healing, while the use of additional materials like erythropoietin (EPO) can enhance the healing process. ^{1 2 3 4 5}

Is gum and bone surgery generally safe for humans?

The studies reviewed focus on the safety of fibula free flaps, a type of bone graft used in reconstructive surgeries, which can have complications like infections, non-union (failure of the bone to heal properly), and donor-site issues. While these studies do not directly address gum and bone surgery, they highlight that such procedures can have risks, and further research is needed to minimize complications. ^{6 7 8 9 10}

How does the Free Gingival Graft treatment differ from other treatments for gum and bone surgery?

The Free Gingival Graft (FGG) is unique because it is a predictable technique for increasing attached gum tissue and can be enhanced with liquid platelet-rich fibrin (PRF) for better root coverage. Additionally, a novel procedure using a donor site from the maxillary tuberosity and a new suture technique can minimize graft shrinkage and improve blood circulation, making it a viable alternative for gum surgery. ^{1 4 5 11 12}

Eligibility Criteria

This trial is for adults with insufficient alveolar ridge width who need dental implants, have good oral hygiene, and can follow the study's procedures. It excludes those with periodontal disease, active infections, liver/kidney issues, uncontrolled diabetes, recent cancer treatment or bone diseases affecting healing.

Inclusion Criteria

The patient and/or guardian is willing and able to comply with pre-operative and post-operative diagnostic and clinical evaluations required

Insufficient alveolar ridge width for endosseous implant placement, defined as 5 mm or less, as determined by bone sounding and CBCT scan

I am 18 years old or older.

Exclusion Criteria

Pregnant or lactating women (self-reported)

I have poor dental health.

The patient is pregnant or breastfeeding

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either free gingival graft surgery before guided bone regeneration or guided bone regeneration followed by free gingival graft

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Free Gingival Graft (Procedure)
• Guided Bone Regeneration (Procedure)

Trial Overview The study compares two sequences of dental surgery: one where a free gingival graft (FGG) is done before guided bone regeneration (GBR), and another where FGG follows GBR to see which order gives better results for patients needing dental implants.

Participant Groups

Group I: FGG before GBR Experimental Treatment 1 Intervention

Free Gingival Graft(FGG) before the guided bone regeneration(GBR)

Group II: FGG after GBR Experimental Treatment 1 Intervention

Free Gingival Graft(FGG) after the guided bone regeneration(GBR)

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Findings from Research

A novel free gingival graft (FGG) procedure using donor tissue from the maxillary tuberosity showed reduced graft shrinkage and improved healing over a 3-year follow-up period.

The new periosteum suture technique and maintaining a 1 mm gap between the graft and muco-gingival junction enhanced blood circulation and revascularization, suggesting this method may be a promising alternative for FGG in dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The perspectives of a novel operative procedure for free gingival graft. Liao, TH., Hsu, MH., Liao, YT., et al.[2023]

In a clinical trial involving 17 patients, the topical application of erythropoietin (EPO) significantly improved healing and reduced inflammation in free gingival grafts by day 28 compared to the control group.

While EPO enhanced the healing process and decreased inflammation, it did not significantly affect the final size of the graft area, indicating that while EPO may aid in the early stages of healing, it does not alter the ultimate graft outcome.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of topical erythropoietin application on the healing outcome of gingival graft recipient site; a randomized controlled clinical trial. Yaghobee, S., Rouzmeh, N., Taheri, M., et al.[2021]

Free gingival grafts (FGGs) effectively maintain the width of keratinized mucosa and reduce mucosal recession around dental implants for up to 48 months, showing better outcomes than implants without surgery.

The study found significantly less crestal bone loss in the FGG group (0 ± 0.4 mm) compared to the no-surgery group (0.4 ± 0.4 mm), indicating that FGGs are a beneficial treatment for implants with limited keratinized mucosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free gingival grafts for implants exhibiting a lack of keratinized mucosa: Extended follow-up of a randomized controlled trial. Oh, SL., Ji, C., Azad, S.[2021]

A comprehensive review of 31 clinical trials on free gingival graft (FGG) and connective tissue graft (CTG) procedures identified key outcome measurements for evaluating palatal wound healing, including hydrogen peroxide tests, tissue color match, and visual inspection.

Postoperative patient-reported morbidity was assessed through common measures such as pain perception, discomfort, and quality of life, highlighting the importance of both clinical and patient-centered evaluations in these surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome measurements following palatal soft tissue graft harvesting: A review. Malpartida-Carrillo, V., Tinedo-Lopez, PL., Guerrero, ME., et al.[2022]

The study involved 32 surgical sites in 16 patients and found that adding liquid platelet-rich fibrin (PRF) to free gingival grafts (FGG) improved healing outcomes, as indicated by better Healing Index scores at 7 and 14 days post-surgery.

While both groups showed reduced gingival recession depth after 6 months, the liquid PRF group demonstrated a trend towards better root coverage, suggesting that PRF may enhance the effectiveness of FGG in treating gingival recessions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liquid platelet-rich fibrin in root surface biomodification during gingival recession treatment: Randomized, controlled, split-mouth, clinical trial. Albatal, W., Qasem, T., Tolibah, YA.[2023]

Free vascularized fibular bone graft (FVFBG) is an effective technique for reconstructing bone after trauma, tumor removal, or congenital deformities, but it carries risks of complications that can lead to additional surgeries and long-term functional impairments.

A review of various studies highlighted that while FVFBG is widely used in areas like limb and mandibular reconstruction, there is a need for more comprehensive research and potential device-based improvements to enhance outcomes and reduce donor-site complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complication of osteo reconstruction by utilizing free vascularized fibular bone graft. Ou, Q., Wu, P., Zhou, Z., et al.[2022]

In a study of 20 patients who received free vascularised fibula flap transfers, 18 grafts were successful, but complications led to 10 re-operations, highlighting the need for careful monitoring post-surgery.

The two unsuccessful grafts required a total of 11 re-operations, primarily due to infections and non-union, indicating that while the procedure can be effective, there are significant risks of complications that may require additional surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The morbidity of the free vascularised fibula flap. Coghlan, BA., Townsend, PL.[2019]

In a study of 85 patients who underwent mandibular continuity reconstruction using fibular free flaps, 43% experienced at least one surgical complication, highlighting the potential risks associated with this procedure.

Risk factors for complications included tobacco use, age over 60, and certain types of mandibular defects, suggesting that careful patient selection and management of comorbidities may help reduce postoperative issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications and Risk after Mandibular Reconstruction with Fibular Free Flaps in Patients with Oral Squamous Cell Carcinoma: A Retrospective Cohort Study. Lodders, JN., Schulten, EA., de Visscher, JG., et al.[2017]

A study assessing donor site morbidity in patients who underwent mandibular reconstruction using a fibula free flap showed significant improvements in pain perception, walking ability, and overall quality of life after 6 months post-surgery, indicating effective recovery.

The point evaluation system used in the study demonstrated that donor site morbidity was low and did not result in major complications, suggesting that harvesting the fibula for reconstruction is a safe procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Donor Site Morbidity Following Fibula Flap Transfer. Maben, D., Anehosur, V., Kumar, N.[2022]

In a study of 157 patients undergoing fibula free flap reconstruction for head and neck defects, 31.2% experienced perioperative complications, with skin graft loss being the most common at 15%.

Despite the high rate of short-term complications, 96% of patients returned to their preoperative level of activity, indicating that long-term functional limitations are rare following the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective cohort study of fibula free flap donor-site morbidity in 157 consecutive patients. Momoh, AO., Yu, P., Skoracki, RJ., et al.[2022]

The use of a free gingival graft (FGG) after tooth extraction effectively serves as a soft tissue barrier, preventing complications like frenal pull.

In this case study, the FGG contributed to good healing of the underlying bone, with a high percentage of new bone formation, suggesting it may enhance the maturation of grafted areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and histomorphometric evaluation of staged approach using bone augmentation and autogenous masticatory mucosal graft with endosseous implant placement: a case report. Park, JB.[2009]

In a study involving 32 maxillary teeth, autogenous free gingival-bone grafts were successfully used to treat post-extraction defects, showing good integration and healing without complications after 12 to 16 weeks.

The results indicate that this grafting technique not only supports the reconstruction of hard and soft tissues but also provides significant esthetic and functional benefits in periodontal and implant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A new technique for bone augmentation and papilla reconstruction with autogenous free gingival-bone grafts. Rebaudi, A., Massei, G., Trisi, P., et al.[2007]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The perspectives of a novel operative procedure for free gingival graft. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Evaluation of topical erythropoietin application on the healing outcome of gingival graft recipient site; a randomized controlled clinical trial. [2021]

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

Free gingival grafts for implants exhibiting a lack of keratinized mucosa: Extended follow-up of a randomized controlled trial. [2021]

4. Spain pubmed.ncbi.nlm.nih.gov

Outcome measurements following palatal soft tissue graft harvesting: A review. [2022]

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

Liquid platelet-rich fibrin in root surface biomodification during gingival recession treatment: Randomized, controlled, split-mouth, clinical trial. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Complication of osteo reconstruction by utilizing free vascularized fibular bone graft. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The morbidity of the free vascularised fibula flap. [2019]

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

Complications and Risk after Mandibular Reconstruction with Fibular Free Flaps in Patients with Oral Squamous Cell Carcinoma: A Retrospective Cohort Study. [2017]

9. India pubmed.ncbi.nlm.nih.gov

Assessment of Donor Site Morbidity Following Fibula Flap Transfer. [2022]

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

A prospective cohort study of fibula free flap donor-site morbidity in 157 consecutive patients. [2022]

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

Clinical and histomorphometric evaluation of staged approach using bone augmentation and autogenous masticatory mucosal graft with endosseous implant placement: a case report. [2009]

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

A new technique for bone augmentation and papilla reconstruction with autogenous free gingival-bone grafts. [2007]