Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted TeethNCT07191262
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 study testing 0.12% CHX and Essential Oil mouthrinse and 2.6% EDTA and 0.2% EDTA mouth rinse in people with Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth
- What is being tested?
- 0.12% CHX and Essential Oil mouthrinse and 2.6% EDTA and 0.2% EDTA mouth rinse
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294-0007
Maria Geisinger, DDS, MS, 205-934-4984, miagdds@uab.edu
Sarah Startley, DMD, 205-975-8711, ss1971@uab.edu
About this study
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.
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.
Read the 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
- Being tested
- 0.12% CHX and Essential Oil mouthrinse, 2.6% EDTA and 0.2% EDTA mouth rinse
- Keywords
- Extraction sites, Ridge preservation grafting, Soft tissue healing, Dimensional ridge changes, Antimicrobial mouth rinse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.12% CHX and Essential Oil mouthrinseOther
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).
2.6% EDTA and 0.2% EDTA mouth rinseOther
.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).
| Study group | Role | What they receive |
|---|---|---|
| 0.12% CHX and Essential Oil mouthrinse | Active comparator | 0.12% CHX and Essential Oil mouthrinse Receives: Other: 0.12% CHX and Essential Oil mouthrinse |
| 2.6% EDTA and 0.2% EDTA mouth rinse | Experimental | 2.6% EDTA and 0.2% EDTA mouth rinse Receives: Other: 2.6% EDTA and 0.2% EDTA mouth rinse |
What is being measured
The primary outcome is the main question the study is designed to answer.
The wound closure after extraction and ridge preservation grafting at 2, 4, and 8, and 12-weeks.
Percentage of wound area closure after extraction and ridge preservation grafting at 2, 4, and 8, and 12 weeks as measured by occlusal photographs in a 1:1 magnification.
Measured: From baseline to 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.
Secondary outcomes (3)
Plaque accumulation at tooth surfaces adjacent to the surgical site
Plaque index at tooth surfaces adjacent to the surgical site at 2, 4, 8, and 12-weeks postoperatively as measured by the Silness and Löe plaque index at 6 sites per tooth at all remaining teeth in the dentition. These measurements will be performed by calibrated dental examiners using a periodontal probe and standardized plaque index categories.
Silness and Loe Plaque index:
Scores of 0, 1, 2, or 3 are assigned to each of 6 tooth surfaces (mesio-buccal, buccal, disto-buccal, disto-lingual, lingual, and mesio-lingual) after 1mm subgingival periodontal probe sweep. The amount of dental plaque present is classified as:
- 0: No plaque detectable
- 1: A thin film of plaque visible only with a probe
- 2: Moderate accumulation of plaque visible to the naked eye at the gingival margin
- 3: Gross plaque accumulation
Measured: From baseline to 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively.
Patient centered outcomes using the Visual Analog Scale (VAS)
Patient centered outcomes including pain, bleeding, swelling, change in daily activities at 2 weeks and 4 weeks postoperatively, using a standardized Visual Analog Scale (VAS) assessing patient-reported outcomes.
Measured: From baseline to 2 weeks and 4 weeks postoperatively.
Ridge width and hard tissue dimensional changes after 12-week postoperative healing.
Three-dimensional ridge hard tissue dimensional changes (ridge width and height) based upon comparison of cone-beam computerized tomography (CBCT) analysis comparing pre-extraction images and images taken prior to dental implant placement (12 weeks post-extraction).
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2025
- Study start2 Mar 2026
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted TeethStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria L. Geisinger, DDS, MS, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191262
- Sponsor's protocol ID
- IRB-300015320
- Other IDs
- UAB Periodontology
- Status last verified
- Mar 2026
- First submitted
- 17 Sep 2025
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07191262
- Acronym / sponsor ID
- IRB-300015320
- Keywords
- Extraction sites, Ridge preservation grafting, Soft tissue healing, Dimensional ridge changes, Antimicrobial mouth rinse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.12% CHX and Essential Oil mouthrinse | Active comparator | Other: 0.12% CHX and Essential Oil mouthrinse0.12% CHX and Essential Oil mouthrinse |
| 2.6% EDTA and 0.2% EDTA mouth rinse | Experimental | Other: 2.6% EDTA and 0.2% EDTA mouth rinse2.6% EDTA and 0.2% EDTA mouth rinse |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.12% CHX and Essential Oil mouthrinse0.12% 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 | 0.12% CHX and Essential Oil mouthrinse |
| 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). | Other | 2.6% EDTA and 0.2% EDTA mouth rinse |
Primary outcome
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.
Percentage of wound area closure after extraction and ridge preservation grafting at 2, 4, and 8, and 12 weeks as measured by occlusal photographs in a 1:1 magnification.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.12% CHX and Essential Oil mouthrinse and 2.6% EDTA and 0.2% EDTA mouth rinse in people with Extraction Sites After Removal and Bone Replacement Grafting at Extraction Sockets of Dentally Hopeless Single-rooted Teeth, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria L Geisinger, DDS, MS (205-934-4984, miagdds@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.