Dry SocketNCT01292343
Triclosan Toothpaste and Third Molar Surgery
A study testing Colgate Total Toothpaste and Colgate Regular Toothpaste in people with Dry Socket and Wound Infection, run by University of Rochester at 1 site in United States.
Trial summary
Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Socket, Wound Infection
- What is being tested?
- Colgate Total Toothpaste and Colgate Regular Toothpaste
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- must include at least one mandibular third molar with partial or full bony impaction
- no sign of active pericoronal (around the crown) infections
- must have not taken antibiotics for any reason in the past 30 days
- must be healthy and between 18 and 35 years of age
- must be able to read and sign an informed consent
Who cannot join
- Subjects with systemic diseases and pregnant or lactating women
- Subjects with advanced periodontal diseases or having two or more untreated caries lesions
- Subjects who cannot read and sign an informed consent
- Subjects with signs of pericoronal infections
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Eastman Dental Center
Rochester, New York, 14620
About this study
Official title: Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery
Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.
Read the detailed description
This study may provide evidence on the effect of triclosan containing dentifrice on oral bacteria and oral inflammation prior to third molar surgery, and on the incidence of inflammatory complications after the surgery. If proven effective, dentifrice containing triclosan may be recommended prior to tooth extractions and replace antibiotics and other antimicrobial products as a prophylactic procedure before oral surgery procedures.
- Conditions
- Dry Socket, Wound Infection
- Being tested
- Colgate Total Toothpaste, Colgate Regular Toothpaste
- Keywords
- third molars, triclosan, toothpaste, dry socket, wound infection
- Medical subject headings
- Dry Socket, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colgate Total ToothpasteOther
Also called triclosan, dentifrice
Toothbrushing with Colgate Total Toothpaste
Colgate Regular ToothpasteOther
Also called fluoride, dentifrice
Toothbrushing with Colgate regular toothpaste
What is being measured
The primary outcome is the main question the study is designed to answer.
dry socket
Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction
Measured: 3 to 7 days
Secondary outcomes (1)
wound infection
Development of tooth extraction wound infection 3 to 7 days after extraction
Measured: 3 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startFeb 2008
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry SocketStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanfang Ren, University of Rochester
- Investigators
- Yanfang Ren, DDS, MPH, Principal investigator, University of Rochester Eastman Dental Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292343
- Sponsor's protocol ID
- UREDC3rd
- Status last verified
- Oct 2015
- First submitted
- 4 Feb 2011
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Triclosan Containing Dentifrice on Oral Bacteria and Postoperative Complications Following Third Molar Surgery
- ClinicalTrials.gov ID
- NCT01292343
- Acronym / sponsor ID
- UREDC3rd
- Conditions
- Dry Socket, Wound Infection
- Keywords
- third molars, triclosan, toothpaste, dry socket, wound infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 9 Feb 2011 (estimated)
- 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.
Triclosan containing dentifrices are effective in the prevention of inflammatory complications following third molar surgery through reducing preoperative oral bacteria load.
Detailed description
This study may provide evidence on the effect of triclosan containing dentifrice on oral bacteria and oral inflammation prior to third molar surgery, and on the incidence of inflammatory complications after the surgery. If proven effective, dentifrice containing triclosan may be recommended prior to tooth extractions and replace antibiotics and other antimicrobial products as a prophylactic procedure before oral surgery procedures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- must include at least one mandibular third molar with partial or full bony impaction
- no sign of active pericoronal (around the crown) infections
- must have not taken antibiotics for any reason in the past 30 days
- must be healthy and between 18 and 35 years of age
- must be able to read and sign an informed consent
Key exclusion criteria (4 listed)
- Subjects with systemic diseases and pregnant or lactating women
- Subjects with advanced periodontal diseases or having two or more untreated caries lesions
- Subjects who cannot read and sign an informed consent
- Subjects with signs of pericoronal infections
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 |
|---|---|---|
| Colgate Total ToothpasteAlso: triclosan, dentifriceToothbrushing with Colgate Total Toothpaste | Other | – |
| Colgate Regular ToothpasteAlso: fluoride, dentifriceToothbrushing with Colgate regular toothpaste | Other | – |
Primary outcome
dry socket
Time frame: 3 to 7 days
Development of dry socket (alveolar osteitis) 3 to 7 days after tooth extraction
1 secondary outcome
wound infection
Time frame: 3 to 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
Related trials for Dry Socket
Recruiting
Effect of Curcumin Topical Spray on Wound Healing After Tooth Extraction
Wound Healing, Alveolitis of Jaw
Not yet recruiting
Comparative Efficacy of Amoxicillin, Metronidazole, and Chlorhexidine in Preventing Alveolar Osteitis
Alveolar Osteitis
Active, not recruiting
Alvogyl Versus Platelet-Rich Fibrin for Healing of Alveolar Osteitis
Alveolar Osteitis
Active, not recruiting
Chlorhexidine Versus Normal Saline Socket Irrigation for Prevention of Dry Socket After Lower Wisdom Tooth Extraction
Alveolar Osteitis, Impacted Lower Third Molar
Not yet recruiting
Effectiveness of Telephonic and Digital Postoperative Follow-up Communication Strategies on Patient Compliance, Clinical Recovery, and Quality of Life After Dental Extraction
Tooth Extraction, Postoperative Care
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. This study is not recruiting at the moment.
Yanfang Ren, DDS, MPH principal investigator
University of Rochester Eastman Dental Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colgate Total Toothpaste and Colgate Regular Toothpaste in people with Dry Socket and Wound Infection, run by University of Rochester 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 28 Oct 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dry socket (time frame: 3 to 7 days). 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 28 Oct 2015.