NCT07191262

To Compare Post-Extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.

A Prospective, Randomized Clinical Trial to Compare Post-extraction Use of a Novel Ethylenediaminetetraacetic Acid (EDTA) Post-operative Mouth Rinse and Daily Use EDTA Mouth Rinse and Standard 0.12% Chlorhexidine (CHX) Post-operative Mouth Rinse and Daily Use Essential Oil (EO) Mouth Rinse.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University of Alabama at Birmingham · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study will compare commercially available, commonly used mouth rinses (0.12% chlorhexidine (CHX) vs. Ethylenediaminetetraacetic acid (EDTA)) for immediate post-operative and daily antiseptic use after tooth extraction and ridge preservation grafting followed by daily use of commercially available an essential oil (EO) mouthrinse and EDTA mouthrinse.

Detailed description

This investigator-initiated study will compare commercially available, commonly used mouth rinses for post-operative and daily antiseptic use after tooth extraction and bone grafting withing the extraction socket. Current protocols for post-extraction antiseptic use often employ the use of broad-spectrum antimicrobial mouth rinse, commonly 0.12% chlorhexidine (CHX), during the immediate post-operative period when patients are often advised not to perform mechanical oral hygiene (e.g. toothbrushing and interdental cleaning) at the surgical site. Further, approximately 25% of individuals use over-the-counter (OTC) therapeutic mouth rinses daily. Concerns have been raised about the broad-spectrum antimicrobial nature of CHX and the potential for cytotoxic effects from CHX, which can negatively impact both the microbiome and tissue healing at the extraction site. EDTA is a chelating agent that can bind to metal cations and has historically been used in OTC dentifrices (toothpastes) and mouthrinses to reduce calcification of plaque biofilm to reduce calculus (tartar) formation. Recent data evaluating the use of EDTA chelators have expanded dental healthcare professional's understanding of potential mechanisms of action of EDTA to include impacts on initial binding of primary bacterial colonizers within dental plaque biofilms to the dental pellicle. Specific aims for this project include the prospective comparison of the following outcomes between the groups during the 12-week healing period: * Wound closure * Plaque index * Adverse healing events * Patient-reported post-operative outcomes including pain, swelling, change in daily activities, and esthetics * Dimensional ridge changes

Conditions

• Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth

Interventions

Type	Name	Description
OTHER	0.12% CHX and Essential Oil mouthrinse	0.12% CHX mouthrinse will be used to rinse for 1 minute with 15 mL twice daily starting day 1 after surgery through day 14. Patients will be instructed to use OTC essential oil mouthrinse 15mL once daily until the conclusion of the study (day 15 to day 84).
OTHER	2.6% EDTA and 0.2% EDTA mouth rinse	.6% EDTA mouthrinse will be used to rinse for 1 minute with 15 mL twice daily starting day 1 after surgery through day 14. Patients will be instructed to use 0.2% EDTA mouthrinse 15mL once daily until the conclusion of the study (day 15 to day 84).

Timeline

• Start date: 2026-03-02
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2025-09-24
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States