Timing of Gum and Bone Surgery

Overseen By Sarah Startley, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Must not be taking: Bisphosphonates, Anti-inflammatories

Disqualifiers: Infectious diseases, Diabetes, Cancer, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the optimal sequence for performing two gum and bone surgeries to enhance dental health, particularly for those requiring implants. It compares the effects of conducting a free gingival graft (gum surgery) before or after guided bone regeneration (bone surgery) to determine which sequence promotes better healing and implant success. Suitable candidates have missing teeth, require dental implants, and possess narrow jawbone areas where implants are necessary. Participants should maintain good oral hygiene and have no health conditions that could impair bone healing. As an unphased trial, this study allows participants to contribute to significant dental research that may improve future treatment strategies.

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.

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

Research shows that a free gingival graft (FGG) is a reliable and safe choice for dental surgery. Although few studies focus specifically on FGG before guided bone regeneration (GBR), FGG itself is well-regarded. It effectively increases strong gum tissue and is considered dependable. Studies have shown that FGG has a high success rate and heals well because it uses tissue from the patient's own mouth, making it very compatible and predictable.

For FGG after GBR, similar safety and effectiveness have been observed. The procedure is known for its success and safety, with predictable healing outcomes. It uses the patient’s own gum tissue, ensuring the body accepts it without issues.

In summary, both sequences involving FGG are considered safe and well-tolerated based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are intrigued by the timing of Free Gingival Graft (FGG) in relation to guided bone regeneration (GBR) to improve outcomes in dental surgery. Unlike traditional approaches where the sequence might not be as strategically considered, this trial explores whether performing the FGG before or after GBR leads to better healing and stability. The excitement lies in potentially optimizing the procedure timing to enhance gum and bone integration, which could lead to more predictable and successful results in dental restoration. This study could reveal insights that refine surgical protocols, ultimately benefiting patients with improved oral health outcomes.

What evidence suggests that this trial's treatments could be effective for gum and bone surgery?

This trial will compare the timing of free gingival grafts (FGG) in relation to guided bone regeneration (GBR). Studies have shown that FGGs effectively increase the tough tissue needed for healthy gums. This procedure is reliable and offers proven long-term benefits. Research indicates that using the patient’s own tissue for these grafts leads to high success rates due to good acceptance and predictable healing. Although fewer studies specifically address FGG before GBR, using FGG before GBR is generally seen as helpful for widening the tough gum tissue. In this trial, one group will receive FGG before GBR, while another group will receive FGG after GBR. Evidence supports both approaches, with patients reporting less pain and better oral health. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

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

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

I don't have any health issues or take medications that could affect bone healing.

Exclusion Criteria

Pregnant or lactating women (self-reported)

I have poor dental health.

The patient is pregnant or breastfeeding

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Free Gingival Graft
• Guided Bone Regeneration

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.

How Is the Trial Designed?

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)

Free Gingival Graft is already approved in United States, European Union for the following indications:

Approved in United States as Free Gingival Graft for:

• Gingival recession
• Periodontal defects
• Soft tissue augmentation around dental implants

Approved in European Union as Free Gingival Graft for:

• Gingival recession
• Periodontal defects
• Soft tissue augmentation around dental implants

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Published Research Related to This Trial

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 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]

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]

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 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 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]

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10373725/

Two-stage method of free gingival graft prior to periodontal ... Free gingival graft (FGG) is an effective surgical procedure to widen the keratinised gingiva, but there are few clinical studies on FGG prior to GTR ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12026320/

Biomaterials for Guided Tissue Regeneration and ... The advantages of autogenous gingival grafts involve a high success rate, since they ensure excellent biocompatibility and predictable healing, ...

3. mdpi.com mdpi.com/2076-3417/12/21/11247

The 'Guided Tissue Regeneration (GTR) Effect' of ... This paper describes a favorable effect of the use of bone lamina in guided bone regeneration. Aside from the expected GBR effect on the edentulous ridges.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0300571223001914

Patient-reported outcomes following guided bone ... This study aims to report patient-centered outcomes (pain, swelling, difficulty of mouth opening, and oral health-related quality of life) and correlate them ...

5. researchgate.net researchgate.net/publication/365174022_The_'Guided_Tissue_Regeneration_GTR_Effect'_of_Guided_Bone_Regeneration_GBR_with_the_Use_of_Bone_Lamina_A_Report_of_Three_Cases_with_More_Than_36_Months_of_Follow-Up

(PDF) The 'Guided Tissue Regeneration (GTR) Effect' of ... The so called 'GTR effect' means that the GBR not only reproduces the required bone volume for placing implants, but also improves attachment levels on the ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2352320424001536

Clinical outcomes of guided tissue regeneration with ... A Case report has been published demonstrating the safety and efficacy of bone regeneration using a PLCL membrane during simultaneous implant placement [26].

7. researchgate.net researchgate.net/publication/392930158_Free_Gingival_Graft_for_Mandibular_Anterior_Teeth_A_Clinical_Case_Report

Free Gingival Graft for Mandibular Anterior Teeth Conclusion: The free gingival graft remains a reliable and effective therapeutic option for increasing keratinized tissue in areas where it is ...