EDTA vs CHX Mouth Rinse for Tooth Extractions

Overseen By Sarah Jane Startley, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama at Birmingham

Disqualifiers: Smokers, Systemic pathologies, Allergies, others

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

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two mouth rinses, chlorhexidine (CHX) and ethylenediaminetetraacetic acid (EDTA), to determine which is more effective for maintaining oral health after tooth extraction and bone grafting. Participants will use one of these rinses immediately after their procedure and continue with either an essential oil mouth rinse or EDTA daily. The trial seeks patients who need a single tooth extracted and have healthy teeth or implants nearby. Those with a single-rooted tooth requiring extraction and a bone graft for future implants may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to dental health research and potentially benefit from innovative oral care solutions.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that chlorhexidine (CHX) mouth rinse is usually safe when used as directed. It serves as a common antiseptic for many dental procedures. Some individuals might experience minor side effects, such as temporary changes in taste or slight mouth irritation.

Studies have found ethylenediaminetetraacetic acid (EDTA) effective for dental uses, such as cleaning root canals. Although these studies did not specifically examine its safety in mouth rinses, they suggest EDTA is used safely in dental treatments. However, it might cause mild effects, like changes in tooth hardness, when combined with other substances.

Overall, both treatments have a history of safe use in dental care, though individual reactions can vary. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using EDTA and CHX mouth rinses for tooth extractions because these treatments aim to improve healing and reduce infections, offering new potential over traditional saltwater rinses. Unlike standard care options that primarily focus on antimicrobial action, the 2.6% and 0.2% EDTA formulations have the potential to aid in wound healing by chelating calcium ions, which might help in reducing inflammation and promoting tissue regeneration. On the other hand, the 0.12% CHX mouth rinse, enhanced with essential oils, offers a dual action: it not only fights bacteria but also adds anti-inflammatory benefits, which could lead to better post-extraction outcomes. These unique approaches could mean faster recovery and less discomfort for patients after dental procedures.

What evidence suggests that this trial's treatments could be effective for post-operative antiseptic use after tooth extraction?

This trial will compare the effectiveness of EDTA and CHX mouth rinses for care after tooth extractions. Research has shown that EDTA, a compound, can improve dental health by aiding tissue healing. Studies have found that treating dentine (the layer under the tooth's enamel) with EDTA releases helpful growth factors and supports new cell growth, suggesting it might aid healing after tooth extractions. Meanwhile, chlorhexidine (CHX) is a well-known antiseptic mouth rinse that effectively reduces oral bacteria and prevents infections after dental work. Both EDTA and CHX have shown promising results, prompting their comparison in this trial to determine which is more effective for post-extraction care. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals who have recently undergone tooth extraction and ridge preservation grafting. Participants should be in good general health and willing to use the assigned mouth rinse as directed post-operatively.

Inclusion Criteria

Able to read and provide informed consent in English

Established and registered patient of the UAB School of Dentistry

I am 18 years old or older.

Exclusion Criteria

Non-English speaking

Smokers/nicotine users (>10 cigarettes or equivalent/day)

Documented or suspected allergy or sensitivity to any study product

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use either 0.12% CHX and Essential Oil mouthrinse or 2.6% EDTA and 0.2% EDTA mouth rinse post-extraction and daily for antiseptic use

12 weeks

Visits at 2, 4, 8, and 12 weeks

Follow-up

Participants are monitored for wound closure, plaque index, and patient-reported outcomes

12 weeks

Visits at 2, 4, 8, and 12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Chlorhexidine (CHX)
• Ethylenediaminetetraacetic Acid (EDTA)

Trial Overview The study is testing two types of mouth rinses: a novel Ethylenediaminetetraacetic Acid (EDTA) rinse compared with the standard Chlorhexidine (CHX) rinse, both used immediately after surgery and then daily alongside an Essential Oil (EO) mouthrinse.

How Is the Trial Designed?

Group I: 2.6% EDTA and 0.2% EDTA mouth rinse Experimental Treatment 1 Intervention

2.6% EDTA and 0.2% EDTA mouth rinse

Group II: 0.12% CHX and Essential Oil mouthrinse Active Control 1 Intervention

0.12% CHX and Essential Oil mouthrinse

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5514805/

A comparative evaluation of the effect of 8% and 17 ... Overall, the results of our study suggest that extensive use of 17% EDTA jeopardizes the integrity of the tooth by weakening the root making it more susceptible ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1079210411003672

Effectiveness of ethylenediaminetetraacetic acid (EDTA ... Within the limitations of this study in a closed system, 17% EDTA and MTAD resulted in almost equally efficient debridement in all thirds of the root canal ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07191262

To Compare Post-Extraction Use of a Novel ... Patient-reported post-operative outcomes including pain, swelling, change in daily activities, and esthetics; Dimensional ridge changes.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8816759/

Effect of 24% EDTA root conditioning on the outcome ... Considering the limitations of the present study, the use of 24% EDTA for root conditioning did not improve 12-month outcomes after treatment of multiple RT1 ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/iej.13728

Influence of ethylenediaminetetraacetic acid on ... High-quality in vitro evidence suggests that EDTA-treated dentine positively influences TGF-β release, cell migration, attachment and differentiation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3357039/

EDTA-S: A novel root conditioning agent - PMC CONCLUSIONS · The etching of surface with EDTA is more effective than saline solution (control group). · EDTA 15% is more effective, when mixed with soft soap ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1111/edt.12973

Outcomes of apexification in immature traumatised necrotic ... The risk for premature tooth loss was 13.5 times higher in calcium hydroxide apexification, approximately 2 to 4 times higher in PAI 3–5, and 5.6 times higher ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9578881/

EDTA Combined with C-Pilot Files and Microultrasound for ... EDTA combined with C-pilot files and mUS can effectively improve the dredging success rate of root canals obstructed by calcification, shorten the dredging ...

9. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1079210407002776

The effect of EDTA, EGTA, EDTAC, and tetracycline-HCl ... Conclusions. The use of EDTA alone or prior to NaOCl resulted in the maximum decrease in dentin microhardness. The softening effect of subsequent NaOCl ...