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

44 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Dexamethasone for bone grafting after tooth extractions?

Research shows that Dexamethasone can significantly reduce pain and swelling after tooth extractions, like third molar surgeries, and decrease the need for strong painkillers. This suggests it may help improve recovery after bone grafting following tooth extractions. ^{1 2 3 4 5}

Is dexamethasone safe for use in humans?

Dexamethasone has been shown to be safe in humans when used to reduce swelling, pain, and other discomforts after dental surgeries, like wisdom tooth removal, with no significant side effects reported in the studies. ^{4 6 7 8 9}

How does the drug dexamethasone differ from other treatments for bone grafting after tooth extractions?

Dexamethasone is unique because it can be administered in different ways, such as submucosal or endo-alveolar, to effectively reduce swelling, pain, and other post-surgical issues after tooth extractions. This anti-inflammatory drug is often used to minimize complications after dental surgeries, making it a versatile option compared to other treatments that may not offer the same level of inflammation control. ^{1 6 9 10 11}

What is the purpose of this trial?

Following the removal of a tooth, a bone graft is often placed in the socket to try to maintain the volume of bone that was there when the tooth was present so that the bone does not "shrink". The bone graft is kept in place with a small piece of material over the top of the tooth socket and with stitches. This procedure is called "Ridge Preservation". Many different materials are used for ridge preservation, including bone allografts (bone grafts derived from a human tissue donor). These bone allografts are dehydrated (dried) during processing. Before using the material in the socket, the material is re-hydrated (wetted). The most common hydrating (wetting) agent is normal saline (sterile salt water), but other hydrating agents such as blood can also be used. The bone allograft used in this study is Food and Drug Administration (FDA) approved.

Research Team

Brian L Mealey, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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 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]

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]

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]

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 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]

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]

References

1. United States 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. [2022]

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

Bisphosphonates inhibit bone remodeling in the jaw bones of rats and delay healing following tooth extractions. [2022]

3. India pubmed.ncbi.nlm.nih.gov

Effect of submucosal injection of dexamethasone on postoperative discomfort after third molar surgery: a prospective study. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Submucosal injection of dexamethasone reduces postoperative discomfort after third-molar extraction: A systematic review and meta-analysis. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Dexamethasone reduces pain and swelling following extraction of third molar teeth. [2022]

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

Effect of dexamethasone on postoperative morbidity after dental rehabilitation in children. [2013]

7. Denmark pubmed.ncbi.nlm.nih.gov

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

8. Korea (South) pubmed.ncbi.nlm.nih.gov

Review of dexamethasone administration for management of complications in postoperative third molar surgery. [2021]

9. Scotland pubmed.ncbi.nlm.nih.gov

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

10. Denmark pubmed.ncbi.nlm.nih.gov

Perioperative dexamethasone reduces post-surgical sequelae of wisdom tooth removal. A split-mouth randomized double-masked clinical trial. [2022]

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

Effect of dexamethasone on root resorption after delayed replantation of rat tooth. [2013]