Chlorhexidine vs Calcium Hydroxide for Tooth Pain

Overseen By C L Fath, D.D.S.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Southern California

Must not be taking: Pain medications, Antibiotics

Disqualifiers: Cracked tooth, Non-restorable tooth, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two treatments, Chlorhexidine (an antiseptic) and Calcium Hydroxide, to determine which better alleviates tooth pain from apical periodontitis, a condition affecting the tip of the tooth root. The main goal is to assess whether 2% Chlorhexidine reduces pain more effectively between dental appointments compared to Calcium Hydroxide. Individuals experiencing tooth pain when biting due to apical periodontitis, who need a root canal, and can speak English or Spanish might be suitable for this study. As a Phase 3 trial, it represents the final step before FDA approval, offering participants the opportunity to contribute to the development of a potentially new standard treatment for tooth pain.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have taken pain medication or antibiotics in the past 3 days before joining.

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

Research has shown that chlorhexidine is generally safe for oral use. It often treats gum diseases and reduces swelling and redness. Some studies indicate it can cause mild side effects, such as tooth staining or changes in taste, especially with prolonged use. These side effects are usually not serious and can be managed.

Calcium hydroxide is also commonly used in dental treatments. Most people tolerate it well, though it can sometimes cause mild discomfort or irritation in the treated area. Overall, previous research and common dental practices consider both chlorhexidine and calcium hydroxide safe for dental use. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for tooth pain?

Researchers are excited about using chlorhexidine for tooth pain because it offers a unique approach compared to standard treatments like over-the-counter pain relievers or antibiotics. Chlorhexidine is an antiseptic that targets bacteria directly in the mouth, which can help reduce inflammation and pain more effectively at the source. Unlike other treatments that may take longer to show results, chlorhexidine's antibacterial properties can potentially provide quicker relief by addressing the underlying causes of tooth pain.

What evidence suggests that Chlorhexidine and Calcium Hydroxide could be effective for reducing tooth pain?

This trial will compare Chlorhexidine and Calcium Hydroxide for tooth pain. Research has shown that chlorhexidine improves oral health. Studies have found that chlorhexidine significantly reduces signs of gingivitis, a gum swelling often caused by bacteria. Chlorhexidine also proves more effective than regular dental cleaning in enhancing oral health. For periodontitis, a gum infection, chlorhexidine reduces symptoms. Conversely, calcium hydroxide is frequently used in dental treatments for its ability to neutralize acids and protect teeth. While both offer benefits, direct comparisons between them in this context are still under investigation in this trial. ^{1 6 7 8 9}

Who Is on the Research Team?

Rafael Roges, D.D.S.

Principal Investigator

Director, Advanced Endodontics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with symptomatic apical periodontitis who need root canal therapy and can consent to treatment. Participants must speak English or Spanish, have a restorable tooth, and not have taken pain medication or antibiotics in the past 3 days.

Inclusion Criteria

able to undergo informed consent process

I have a tooth that can be fixed.

I need a root canal treatment.

Exclusion Criteria

I have a cracked tooth.

I have a tooth that cannot be fixed.

I haven't taken any pain medication or antibiotics in the last 3 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 2% Chlorhexidine or Calcium Hydroxide as an intracanal medicament

1 week

1 visit (in-person)

Follow-up

Participants are monitored for pain perception and adverse events post-treatment

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Calcium Hydroxide
• Chlorhexidine

Trial Overview

The study compares two treatments for gum disease-related pain: Chlorhexidine (CHX) versus Calcium Hydroxide (CH). It aims to determine if CHX is better at reducing pain between dental appointments than CH.

How Is the Trial Designed?

Group I: Clorhexidine Experimental Treatment 1 Intervention

2% Chlorhexidine

Group II: Calcium Hydroxide Active Control 1 Intervention

Calcium Hydroxide

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9275362/

Chlorhexidine in Dentistry: Pharmacology, Uses, and ...

Rinsing daily with a 0.2% CHX mouthwash for 4 to 6 weeks also resulted in reduced clinical signs of gingivitis in several studies. However, CHX ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10613372/

Effectiveness of chlorhexidine gels and chips in ...

Chlorhexidine gel can be used as an adjunct for scaling and root planing and is more effective than scaling and root planing alone in the ...

3.

mdpi.com

mdpi.com/2079-6382/12/10/1552

Efficacy of Chlorhexidine after Oral Surgery Procedures on ...

The results point out that the application of CHX was significantly more effective, compared to controls where CHX was not employed, providing better wound ...

4.

researchgate.net

researchgate.net/publication/362033720_Comparison_of_Effect_of_Chlorhexidine_Mouthwash_and_Tooth_Paste_after_Periodontal_Surgery_A_Case_Series

Comparison of Effect of Chlorhexidine Mouthwash and ...

Conclusion: Chlorhexidine mouthwash without an anti-discoloration system resulted in significantly lowered plaque and gingival index compared to ...

5.

cochranelibrary.com

cochranelibrary.com/content?templateType=related&urlTitle=/central/doi/10.1002/central/CN-02148059&doi=10.1002/central/CN-02148059&p_p_id=scolariscontentdisplay_WAR_scolariscontentdisplay&_scolariscontentdisplay_WAR_scolariscontentdisplay_action=related-content&p_p_lifecycle=0&p_p_mode=view&type=central&contentLanguage=

Effectiveness of chlorhexidine on patients with periodontitis

Effectiveness of chlorhexidine on patients with periodontitis. Kannan B, Ramamurthy J, Mani G, Ganapathy D. Drug invention today, 2020, 13(4), 606‐ ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7567658/

Current uses of chlorhexidine for management of oral disease

Cochrane review found no conclusive evidence with clinical outcomes, namely pain and swelling, to advise that CHX, compared to other ...

7.

mayoclinic.org

mayoclinic.org/drugs-supplements/chlorhexidine-oral-route/description/drg-20068551

Chlorhexidine (oral route) - Side effects & dosage

Chlorhexidine is used to treat gingivitis. It helps to reduce the inflammation (redness) and swelling of your gums and to reduce gum bleeding.

8.

mayoclinic.org

mayoclinic.org/drugs-supplements/chlorhexidine-periodontal-route/description/drg-20068543

Chlorhexidine (periodontal route) - Side effects & dosage

Chlorhexidine is used to help treat periodontal disease (a disease of your gums), which is caused by bacteria growing beneath the gum line.

9.

goodrx.com

goodrx.com/chlorhexidine/what-is?srsltid=AfmBOorBFHI0g3a_62tKZaD_BK8XPfHY1ub6-30RxxjilLW6eiPKWwNO

Chlorhexidine (Peridex): Uses, Side Effects, Warnings & ...

Using chlorhexidine (Peridex) long-term can raise your risk of side effects, such as staining of your teeth, bacterial resistance to the ...