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

40 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, but you cannot have taken pain medication or antibiotics in the past 3 days before joining.

What data supports the effectiveness of the drug Chlorhexidine vs Calcium Hydroxide for tooth pain?

Research shows that both calcium hydroxide and chlorhexidine are effective in killing bacteria commonly found in failed dental treatments, and they both help reduce postoperative pain. Chlorhexidine, in particular, has shown strong antibacterial effects, while calcium hydroxide is known for its pain-preventive properties. ^{1 2 3 4 5}

Is it safe to use chlorhexidine and calcium hydroxide for dental treatments?

Both chlorhexidine and calcium hydroxide are generally considered safe for use in dental treatments, such as root canal procedures, and have been used effectively to kill bacteria. However, more studies are needed to fully understand their safety and effectiveness when used together. ^{1 2 3 6 7}

How does the drug combination of chlorhexidine and calcium hydroxide differ from other treatments for tooth pain?

The combination of chlorhexidine and calcium hydroxide is unique because it combines the antimicrobial properties of chlorhexidine with the high pH of calcium hydroxide, which is effective in killing bacteria like Enterococcus faecalis. This combination may offer enhanced effectiveness compared to using either agent alone, although further studies are needed to confirm its superiority. ^{1 2 4 6 8}

What is the purpose of this trial?

This is a Pilot Phase III single-blind randomized controlled clinical trial in patients, aged 18 years and older, presenting with symptoms of apical periodontitis. The overall goal is to assess whether 2% Chlorhexidine (CHX) is superior to Calcium Hydroxide in reducing interappointment pain.

Research Team

Rafael Roges, D.D.S.

Principal Investigator

Director, Advanced Endodontics

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

References

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

The effectiveness of various disinfectants used as endodontic intracanal medications: an in vitro study. [2022]

2. Belgium pubmed.ncbi.nlm.nih.gov

[Comparison of calcium hydroxide and chlorhexidine as intracanal medications in endodontics: review of the literature]. [2013]

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

Effectiveness of selected materials against Enterococcus faecalis: part 3. The antibacterial effect of calcium hydroxide and chlorhexidine on Enterococcus faecalis. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Postoperative pain following the use of two different intracanal medications. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Influence of calcium hydroxide on the post-treatment pain in Endodontics: A systematic review. [2021]

6. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Incidence of postoperative pain after use of calcium hydroxide mixed with normal saline or 0.2% chlorhexidine digluconate as intracanal medicament in the treatment of apical periodontitis. [2020]

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

Efficacy of chlorhexidine as a final irrigant in one-visit root canal treatment: a prospective comparative study. [2019]

8. Pakistan pubmed.ncbi.nlm.nih.gov

Comparison Of Two Intracanal Medicaments In Resolution Of Apical Radiolucency. [2022]