A study to test the effect of a new treatment designed to improve the outcome of infected sockets following tooth extraction.

Not Applicable

Completed

• Conditions: Dry socket or alveolar osteitis; Oral Health; Alveolar osteitis

• Registration Number: ISRCTN14300834
• Lead Sponsor: niversity of Bristol

Brief Summary

2018 results in https://www.ncbi.nlm.nih.gov/pubmed/29382467

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-12-04
• Study Completion: 2015-03-13
• Last Update Posted: 4 November 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

1. Consent Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
2. Age Aged at least 18 years
3. Compliance Understands and is willing, able and likely to comply with all study procedures and restrictions
4. General Health Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination
5. Oral Cavity Have a dry socket following tooth extraction as determined by clinical assessment

Exclusion Criteria

1. Breast-feeding Women who are breast–feeding.
2. Disease
2.1. Current or recurrent disease/dental pathology that could affect the assessments.
2.2. Bleeding disorders.
2.3. Immuno-compromised.
2.4. Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, or any medical disorder that may require treatment or make the participant unlikely to fully complete the study, or any condition that presents undue risk from the study products or procedures.
3. Allergy/Intolerance Known or suspected intolerance or sensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
4. Medication- Any medication which in the Investigators opinion may interfere with the study
5. Clinical Study/Experimental Medication-Participation in another clinical study or receipt of an investigational drug within 10 days of the screening visit.
6. Substance abuse Recent history of alcohol or other substance abuse.
7. Personnel A member of the study site or a family relative. The study site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate.
8. Any patient who, in the judgement of the investigator, should not participate in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Clinical Inflammation score (determined by the clinician):<br> 0 = absence,<br> 1 = slight swelling and hardness,<br> 2 = facial planes blurring without affectation of nasolabial folds or eyes;<br> 3 = facial planes blurring with affectation of nasolabial folds and eyes.<br>

Secondary Outcome Measures

Name	Time	Method
Pain and patient perceived surgical outcome as determined by Visual Analogue Score (VAS).