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.

Official title

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.

Overview

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

Interventions

• 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).

Primary outcome measures

• The wound closure after extraction and ridge preservation grafting at 2, 4, and 8, and 12-weeks. [Time frame: From baseline to 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.]

Secondary outcome measures (3)

• Plaque accumulation at tooth surfaces adjacent to the surgical site [Time frame: From baseline to 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.]
• Patient centered outcomes using the Visual Analog Scale (VAS) [Time frame: From baseline to 2 weeks and 4 weeks postoperatively.]
• Ridge width and hard tissue dimensional changes after 12-week postoperative healing. [Time frame: 12 weeks]

Eligibility criteria

Inclusion criteria

• Able to read and provide informed consent in English
• At least 18 years old
• Established and registered patient of the UAB School of Dentistry
• Patients presenting with one single rooted tooth determined to need extraction and simultaneous ridge preservation bone grafting for future dental implant placement.
• Presence of periodontally healthy, non-carious neighboring teeth and/or healthy restored dental implants on either side of the tooth planned for extraction.
• No anticipated need for surgical and/or endodontic care at teeth adjacent to the proposed surgical site during the study period.

Exclusion criteria

• Non-English speaking
• Age less than 18 years old or older than 85 years old
• Smokers/nicotine users (>10 cigarettes or equivalent/day)
• Patients with systemic pathologies or conditions contraindicating oral surgical procedures or adversely affecting wound healing
• Multiple adjacent teeth require extraction and grafting
• Absence of adjacent teeth/implants on either side of the tooth to be extracted.
• Documented or suspected allergy or sensitivity to any study product

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT07191262 · IRB-300015320 · UAB Periodontology

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗