Dexamethasone for Bone Grafting After Tooth Extractions

Overseen By Angela Palaiologou-Gallis, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The University of Texas Health Science Center at San Antonio

Must not be taking: Chemotherapy, Immunosuppressants, Bisphosphonates, Steroids

Disqualifiers: Pregnancy, Smoking, Diabetes, Autoimmune, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

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 tests whether dexamethasone (a type of steroid) as a wetting agent for bone grafts after tooth extraction can better preserve bone compared to the usual saline solution. The goal is to determine if dexamethasone can prevent bone shrinkage, which is crucial for those planning dental implants. Suitable candidates for this trial have a single tooth needing extraction (excluding molars), are planning for a dental implant, and have sufficient bone height in the area. As an Early Phase 1 trial, this research focuses on understanding how dexamethasone works in people, offering participants a chance to contribute to groundbreaking advancements in dental treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on chemotherapeutic or immunosuppressive agents, or have a history of bisphosphonate use or long-term steroid therapy, you may not be eligible to participate.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research shows that dexamethasone is safe for use in dental surgeries, such as wisdom tooth removal, to reduce swelling and pain. Studies have found that low doses of dexamethasone for a short period are generally safe unless specific health conditions make it risky.

In dental care, dexamethasone effectively manages discomfort. This trial tests its new use: hydrating bone grafts after tooth extraction. Although this trial is in the early stages, existing evidence supports its safe use in similar dental procedures. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard care of using normal saline for bone graft hydration after tooth extractions, this treatment uses dexamethasone, a powerful anti-inflammatory steroid. Researchers are excited because dexamethasone might enhance bone healing by reducing inflammation more effectively than saline. This approach could potentially lead to faster recovery and better bone graft integration, offering significant improvements over existing methods.

What evidence suggests that dexamethasone might be an effective treatment for ridge preservation after tooth extractions?

Research shows that dexamethasone can improve recovery after dental surgeries. In this trial, participants in the experimental treatment group will receive an allograft hydrated with a 4mg/1ml dexamethasone solution immediately following tooth extraction. One study found that injecting 4mg of dexamethasone under the gum reduces swelling and pain after surgery, allowing for faster recovery and increased comfort. Additionally, using dexamethasone in bone grafting has proven safe, with no major problems reported. Evidence also indicates that wounds heal better with dexamethasone than without it. ^{2 3 4 6 7}

Who Is on the Research Team?

Brian L Mealey, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

This trial is for individuals needing a tooth extraction followed by bone grafting, known as 'Ridge Preservation'. Participants should be suitable candidates for receiving a bone allograft. Specific inclusion and exclusion criteria details are not provided.

Inclusion Criteria

I need one tooth pulled out, but it's not a molar.

I have enough jawbone height for the procedure, without affecting my sinus or nerve canal.

I am scheduled to get a dental implant for my missing tooth.

Exclusion Criteria

I do not have active infections, poor bone health for dental implants, or conditions affecting healing like uncontrolled diabetes.

Pregnant women or women intending to become pregnant during the study period (as confirmed verbally; an over-the-counter pregnancy test will be provided if pregnancy status is unknown or suspected). Patients who become pregnant during the study will be withdrawn and standard care will be delivered

Smokers who smoke >10 cigarettes per day

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Tooth extraction followed by ridge preservation using allograft hydrated with either dexamethasone or saline

1 day

1 visit (in-person)

Healing

Healing period to allow for new bone formation in the tooth socket

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including measurement of bone formation and ridge dimensions

16 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dexamethasone

Trial Overview The study tests the effectiveness of rehydrating freeze-dried bone allografts with dexamethasone solution compared to saline during ridge preservation after tooth extractions. The goal is to see if dexamethasone improves outcomes.

How Is the Trial Designed?

Group I: Ridge preservation test group Experimental Treatment 1 Intervention

Patients will be randomized to one of the experimental treatment group immediately following tooth extraction and debridement of the socket (test: hydration of allograft with 4mg/1ml dexamethasone solution)

Group II: Ridge preservation control group Active Control 1 Intervention

Patients will be randomized to the control group immediately following tooth extraction and debridement of the socket (control: hydration of allograft with normal saline solution)

Dexamethasone is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases
• Immune system disorders

Approved in United States as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders
• Neoplastic diseases
• Nervous system disorders

Approved in Canada as Dexamethasone for:

• Inflammation
• Allergic reactions
• Respiratory diseases
• Skin conditions
• Eye diseases

Approved in Japan as Dexamethasone for:

• Inflammatory conditions
• Allergic states
• Respiratory diseases
• Blood disorders

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Published Research Related to This Trial

In a study of 50 adult patients undergoing multiple third molar extractions, a single dose of oral dexamethasone (8 mg) significantly reduced postoperative pain and eliminated the need for opioid pain relief.

Dexamethasone also decreased the incidence of severe swelling and reduced postoperative nausea and vomiting, suggesting it can improve recovery and facilitate same-day discharge after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dexamethasone reduces pain and swelling following extraction of third molar teeth. Baxendale, BR., Vater, M., Lavery, KM.[2022]

In a double-blind study involving 30 healthy individuals, the administration of 4 mg dexamethasone before the removal of impacted mandibular third molars resulted in a 50% reduction in postoperative swelling and trismus, and a 30% reduction in pain.

The study found no significant complications from the steroid injection, indicating that prophylactic steroid treatment is both effective and safe for managing postoperative reactions in third molar surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decadronphosphate in the relief of complaints after third molar surgery. A double-blind, controlled trial with bilateral oral surgery. Pedersen, A.[2022]

In a study involving 52 maxillary first molar teeth from 26 rats, the use of dexamethasone after delayed tooth replantation significantly reduced root resorption compared to the dried-only group, indicating its potential efficacy in improving tooth replantation outcomes.

The dexamethasone-treated group also showed significantly more bone ankylosis than the dried-only group, suggesting that while dexamethasone helps in reducing resorption, it may also promote ankylosis, highlighting the need for careful consideration in its application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on root resorption after delayed replantation of rat tooth. Kum, KY., Kwon, OT., Spängberg, LS., et al.[2013]

In a study of 30 patients undergoing removal of impacted lower third molars, both submucosal and intramuscular administration of dexamethasone significantly reduced postoperative swelling and pain compared to a control group without steroids.

Submucosal dexamethasone was particularly effective in reducing trismus on the first day after surgery, and both administration routes were found to be equally effective, making submucosal delivery a safe and non-invasive option for managing postoperative complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of submucosal and intramuscular dexamethasone on postoperative sequelae after third molar surgery: comparative study. Majid, OW., Mahmood, WK.[2022]

In a study of 150 patients undergoing lower third molar extraction, a submucosal injection of 2 mg dexamethasone significantly reduced trismus in patients younger than 25 years old, indicating its efficacy in this demographic.

For females and patients older than 25, a higher dosage of 4 mg dexamethasone was necessary to effectively reduce facial swelling, highlighting the importance of dosage adjustment based on age and gender.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of two dosages of dexamethasone administered by submucosal injection on postoperative sequelae after third molar surgery: A retrospective study. Vasselli, M., Camurri Piloni, A., Greco, C., et al.[2022]

Dexamethasone (DX) significantly reduces both early and late postoperative edema after third-molar extraction, with a large effect size indicating its efficacy in managing swelling.

Patients receiving DX also experienced less early trismus compared to controls, suggesting it may be beneficial for reducing jaw stiffness after surgery, although more research is needed to confirm its effects on late trismus and pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Submucosal injection of dexamethasone reduces postoperative discomfort after third-molar extraction: A systematic review and meta-analysis. Chen, Q., Chen, J., Hu, B., et al.[2022]

In a study involving 43 patients undergoing lower third molar extractions, both endo-alveolar and sub-mucosal administration of dexamethasone significantly reduced postoperative complications like facial swelling, trismus, and pain compared to control sites without steroid treatment.

There were no significant differences in efficacy between the different administration methods or dosages of dexamethasone, indicating that both approaches are effective for managing postoperative inflammation after wisdom tooth removal.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative dexamethasone reduces post-surgical sequelae of wisdom tooth removal. A split-mouth randomized double-masked clinical trial. Graziani, F., D'Aiuto, F., Arduino, PG., et al.[2022]

The combination of zoledronic acid (ZA) and dexamethasone (DX) significantly inhibits bone remodeling and increases the formation of sequestra in rats after tooth extraction, suggesting a potential risk for complications like osteonecrosis of the jaw (BRONJ).

Rats treated with both ZA and DX showed the highest bone-to-tissue volume on the non-extracted side, indicating that while the combination may enhance certain aspects of bone density, it could also lead to adverse effects such as increased sequestra formation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bisphosphonates inhibit bone remodeling in the jaw bones of rats and delay healing following tooth extractions. Jabbour, Z., El-Hakim, M., Henderson, JE., et al.[2022]

In a study of 100 patients undergoing third molar surgery, a 4 mg submucosal injection of dexamethasone significantly reduced postoperative edema compared to a control group that received no medication.

While dexamethasone effectively decreased swelling, there were no significant differences in pain or jaw movement (trismus) between the dexamethasone and control groups, indicating its primary benefit is in reducing swelling rather than pain relief.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. Nair, RB., Rahman, NM., Ummar, M., et al.[2019]

In a study of 200 children undergoing dental surgery, dexamethasone at a dose of 0.3 mg·kg(-1) did not significantly reduce pain levels or improve oral intake compared to a placebo (normal saline) over 24 hours postoperatively.

However, dexamethasone significantly reduced the incidence of postoperative vomiting, with only 1 out of 87 patients in the dexamethasone group experiencing vomiting compared to 8 out of 91 in the placebo group, indicating a potential benefit in managing postoperative nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of dexamethasone on postoperative morbidity after dental rehabilitation in children. McIntyre, RE., Hardcastle, C., Eng, RL., et al.[2013]

Dexamethasone is effective in reducing postoperative pain, swelling, and trismus after third molar surgeries by inhibiting inflammatory mediators, which enhances patient recovery.

The article provides guidance on the optimal routes of administration, dosages, and timing for dexamethasone use in these surgical procedures, ensuring better management of postoperative symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of dexamethasone administration for management of complications in postoperative third molar surgery. Selvido, DI., Bhattarai, BP., Niyomtham, N., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3521834/

Effectiveness of Submucosal Dexamethasone to Control ... Submucosal dexamethasone 4mg injection is an effective therapeutic strategy for swift and comfortable improvement after surgical procedure.

2. withpower.com withpower.com/trial/dexamethasone-for-bone-grafting-after-tooth-extractions-49199

Dexamethasone for Bone Grafting After Tooth Extractions The study found no significant complications from the steroid injection, indicating that prophylactic steroid treatment is both effective and safe for managing ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213398425002921

Evaluation of post dental extraction wound healing and ... Results. The osteogenic group showed significantly better wound healing as compared to the non-osteogenic group at the end of 7th day following ...

4. journals.lww.com journals.lww.com/aoms/fulltext/2020/10010/efficacy_of_various_routes_of_dexamethasone.12.aspx

Annals of Maxillofacial Surgery The IV group showed minimal swelling and better pain control on the 3rd post op day (statistically significant). All 4 routes showed comparable mouth opening ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/ccr3.6589

Submucosal administration of dexamethasone for dental ... Submucosal dexamethasone delivered at an implant surgical site may prevent post-operative pain and swelling.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12224350/

Effect of different administration methods of dexamethasone ... Some articles have also indicated that taking 8 mg of dexamethasone orally 1 h before surgery significantly reduced pain at 4 to 8 h post- ...

7. mdpi.com mdpi.com/2313-7673/7/2/43

Clinical and Radiological Outcomes for Guided Implant ... The goal of the study was to evaluate marginal bone loss (MBL) after 1-year implant placement using a guided implant surgical (GIS) protocol in grafted sockets.