Tooth Extractions
Conditions
Keywords
Hemostasis, tooth extractions, third molar
Brief summary
The purpose of this study is to determine if the HemCon Dental Dressing is effective in stopping bleeding during dental surgeries.
Detailed description
The HemCon® Bandage has been successfully used to achieve hemostasis in patients with high systolic pressure, high blood volume wounds, and to promote hemostasis on a massive scale compared to the hemostasis requirements of oral surgery wounds. Therefore, a human clinical trial has recently been completed evaluating the efficacy of using the HemCon® Bandage in a smaller finished size for dental extraction and other oral surgery sites. The HemCon® Bandage was proven to be significantly better at promoting hemostasis of oral surgery wounds than the control (cotton gauze or Gelfoam) in all subjects tested. All HemCon® Bandage sites achieved hemostasis faster than the control sites. Based on this data, a 510(k) was submitted and has received FDA clearance for the HemCon® Dental Dressing to be used as an oral wound dressing intended as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. This study evaluates the FDA cleared HemCon® Dental Dressing for use in hemostasis of soft oral tissue subsequent to dental surgical procedures such as tooth extractions excluding procedures involving primary closure of the HemCon® Dental Dressing within the oral wound.
Interventions
DEVICEHemcon Dental Dressing
The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
DEVICEGauze with Pressure and/or Gelfoam
Common practice for oral surgery patients involves the use of sterile dressing over the extraction site. The subject will provide the pressure by biting down on the sterile gauze. As previously discussed, other practices involve the use of Gelfoam prior to application of sterile gauze.
Sponsors
HemCon Medical Technologies, Inc
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients requiring 2 or 4 3rd molar tooth extraction procedures. * Index pairing must reflect anatomically similar extraction locations, i.e., for 2 extractions both must be upper or both must be lower extractions. * Patients must be 14 years of age or older * Patients must be available for a minimum of one post operative evaluation to be scheduled at the time of the procedure approximately 7 days post surgery. Additional follow-up visits may be scheduled at the discretion of the surgeon based on the severity of particular patient cases or the patient's need for earlier follow-up. * Extraction sites do not require primary closure or suturing * Willingness and ability to provide informed consent/ assent for participation * Patients with seafood allergies * Patients who have discontinued the use of anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) for a minimum of 3 days prior to their planned surgical visit.
Exclusion criteria
* Scheduled to undergo a surgical procedure other than 3rd molar tooth extractions * Scheduled to undergo 2 extractions whereby one is an upper 3rd molar and the other is a lower 3rd molar. These will not reflect a proper index pairing for statistical calculations and data analysis based on anatomical similarities. * Extraction procedures are expected to require primary closure or suturing of the HemCon® Dental Dressing within the oral wound. * Unable or unwilling to provide informed consent/ assent for participation as a subject * Patients who are currently taking anticoagulant medications (e.g., aspirin, coumadin, Plavix, etc.) or have discontinued their anticoagulant medications less than 3 days prior to their surgical visit. * Patients who are undergoing bisphosphonate therapy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Hemostasis | Minutes After Application | This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention. |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Post Surgical Sequelae | 1 week post surgery |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited as they presented at the site of the study for extraction. Subjects served as their own control as they had four extractions per procedure and two served as the experimental sites and two served as the control sites.
Participants by arm
| Arm | Count |
|---|---|
| Hemcon Dental Dressing and Gauze With Pressure In the case of this study, participants served as their own control. | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Hemcon Dental Dressing and Gauze With Pressure |
|---|---|
| Age, Categorical <=18 years | 30 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Age Continuous | 19.1 years STANDARD_DEVIATION 3.95 |
| Diastolic Blood Pressure | 73.3 mmHg STANDARD_DEVIATION 8.36 |
| Region of Enrollment United States | 72 participants |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 38 Participants |
| Systolic Blood Pressure | 128.1 mmHg STANDARD_DEVIATION 15.13 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 71 |
| serious Total, serious adverse events | 0 / 71 |
Outcome results
Primary
Time to Hemostasis
This outcome measures the time it takes in minutes for the subject's extraction site to stop bleeding. It is divided by intervention.
Time frame: Minutes After Application
Population: Participants served as their own control thus the total amount of participants is reflected in both of the outcome measures.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| HemCon | Time to Hemostasis | 1.9 Minutes | Standard Error 1.36 |
| Control: Gauze | Time to Hemostasis | 9.8 Minutes | Standard Error 3.96 |
| Total | Time to Hemostasis | 6.0 Minutes | Standard Error 5.09 |
Secondary
Incidence of Post Surgical Sequelae
Time frame: 1 week post surgery
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HemCon | Incidence of Post Surgical Sequelae | Gingival Inflammation: None | 85.3 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Healing Score: HemCon Better than Control | 0 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Gingival Inflammation: Moderate | 0 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Healing Score: HemCon Worse than Control | 0 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Healing Score: HemCon Same as Control | 0 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Pain Score: Moderate | 14.7 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Pain Score: Mild | 38.2 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Pain Score: None | 41.2 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Gingival Inflammation: Mild | 11.8 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Pain Score: Severe | 2.9 Percent of Participants |
| HemCon | Incidence of Post Surgical Sequelae | Gingival Inflammation: Severe | 0 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Healing Score: HemCon Same as Control | 0 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Pain Score: Mild | 38.9 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Pain Score: None | 55.6 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Pain Score: Moderate | 0 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Pain Score: Severe | 0 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Healing Score: HemCon Better than Control | 0 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Healing Score: HemCon Worse than Control | 0 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Gingival Inflammation: None | 77.8 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Gingival Inflammation: Mild | 5.6 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Gingival Inflammation: Moderate | 11.1 Percent of Participants |
| Control: Gauze | Incidence of Post Surgical Sequelae | Gingival Inflammation: Severe | 0 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Gingival Inflammation: Moderate | 7.4 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Gingival Inflammation: None | 73.5 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Pain Score: Moderate | 10.3 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Pain Score: Mild | 44.1 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Gingival Inflammation: Mild | 16.2 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Pain Score: None | 41.2 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Healing Score: HemCon Same as Control | 29.4 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Healing Score: HemCon Better than Control | 14.7 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Gingival Inflammation: Severe | 0 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Healing Score: HemCon Worse than Control | 4.4 Percent of Participants |
| Total | Incidence of Post Surgical Sequelae | Pain Score: Severe | 1.5 Percent of Participants |