A study to test the effect of a new treatment designed to improve the outcome of periodontal surgery

Not Applicable

Completed

• Conditions: Periodontal disease; Oral Health

• Registration Number: ISRCTN31193447
• Lead Sponsor: niversity of Bristol (UK)

Brief Summary

2018 results in https://pubmed.ncbi.nlm.nih.gov/29382467/ (added 24/07/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-25
• Study Completion: 2015-04-24
• Last Update Posted: 3 August 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 38

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. Aged at least 18 years old
3. Understands and is willing, able and likely to comply with all study procedures and restrictions
4. 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 at least 2 vertical interproximal periodontal defects in different quadrants of the mouth as evidenced by radiographic investigation
6. Oral Hygiene Status - Full mouth Turesky plaque index score <2
7. Non-Smoker - Participant must be a non-smoker or have stopped smoking for ?6 months prior to surgery

Exclusion Criteria

1. Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
2. Women who are breast?feeding
3. Disease:
3.1. Current or recurrent disease/dental pathology that could affect the assessments
3.2. Bleeding disorders
3.3. Immuno-compromised
3.4. 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
3.5. Tooth with >grade I mobility
4. Allergy/Intolerance Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
5. Medication: Use of antibiotics one month prior to start of the study
6. Clinical Study/Experimental Medication: Participation in another clinical study or receipt of an investigational drug within 10 days of the screening visit
7. Substance abuse Recent history of alcohol or other substance abuse
8. 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
9. Any participant 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
The change in clinical attachment (pocket depth and gingival recession) measured in mm at the final visit. Measured at 1-2 weeks and 8-12 weeks

Secondary Outcome Measures

Name	Time	Method
Pain assessed by VAS score in mm at 1-2 weeks and 8-12 weeks