Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| UAB Periodontology | Other Identifier | University of Alabama at Birmingham |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.12% CHX and Essential Oil mouthrinse | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.12% CHX and Essential Oil mouthrinse | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 2 weeks, 4 weeks, 8 weeks and 12 weeks postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maria L Geisinger, DDS, MS | Contact | 205-934-4984 | miagdds@uab.edu | |
| Sarah Jane Startley, DMD | Contact | 205-975-8711 | ss1971@uab.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Recruiting | Birmingham | Alabama | 35294-0007 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 2.6% EDTA and 0.2% EDTA mouth rinse | Other | .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). |
|
| 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. | 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). | 12 weeks |
| ID | Term |
|---|---|
| D004492 | Edetic Acid |
| ID | Term |
|---|---|
| D005029 | Ethylenediamines |
| D003959 | Diamines |
| D011073 | Polyamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
Not provided
Not provided