Feasibility study of e-cigarettes in periodontitis

Not Applicable

Completed

• Conditions: Oral Health; Specialty: Oral and dental health, Primary sub-specialty: Oral and dental public health; UKCRC code/ Disease: Oral and Gastrointestinal/ Diseases of oral cavity, salivary glands and jaws; Periodontitis

• Registration Number: ISRCTN17731903
• Lead Sponsor: ewcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31171977 results (added 10/06/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-27
• Study Completion: 2018-11-30
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. Aged over 18 years old
2. Smoker of burnt tobacco (=10 factory-made cigarettes/day or 7 g [0.25 oz] loose tobacco or 14 hand-rolled cigarettes/day)
3. Not currently using an EC, or not used one for more than two days in the last 30 days
4. Be willing and able to come to the Dental Clinical Research facility in the Newcastle Dental Hospital for the required study visits
5. Minimum of 20 natural teeth (excluding third molars)
6. Diagnosed with severe chronic periodontal disease having interproximal pocket probing depths (PPDs) of =5 mm at =8 teeth and BOP scores =30%
7. Have read, understood and signed an informed consent form

Exclusion Criteria

1. Having used an e-cigarette for more than 2 days in the last 30 days
2. Infectious or systemic diseases that may be unduly affected by participation in this study
3. Haemodynamically unstable patients hospitalised with severe arrhythmias, myocardial infarction, cerebrovascular accident
4. Suffering from Phaeochromocytoma
5. Suffering from uncontrolled hyperthyroidism
6. Liver or Kidney problems
7. Chronic Obstructive Pulmonary Disease
8. Patients taking the medication Adenosine
9. Lack of capacity to be able to consent to the research project and/or inability to follow study instructions
10. Participation in a dental research study within the previous 20 days
11. Pregnant by medical history, or nursing
12. Received any non-surgical periodontal therapy other than a routine scale and polish in the last 6 months
13. Currently undergoing or requiring extensive dental, orthodontic or implant treatment, or treatment for peri-implantitis

Eligibility Criteria requiring further discussions with individual participants:
1. Asthma (Severity needs to be assessed. Patient made aware that NRT better than smoking but best to use NRT as a short term stop smoking treatment).
2. Long term throat disease (Severity needs to be assessed. NRT use may exacerbate symptoms)
3. Stomach Ulcer, duodenal ulcer, irritation or inflammation of the stomach or throat (NRT may exacerbate symptoms)
4. Patient with diabetes mellitus will be advised to monitor their blood glucose more closely when initiating treatment. They will be advised to discuss this with their doctor or diabetic nurse.
5. Patients taking medications metabolised by CYP 1A2 and that have a narrow therapeutic window can be affected by stopping smoking. Patients taking theophylline, clozapine and ropinirole will be asked to see their doctor to discuss changing the dose prior to starting the quit attempt.

Study & Design

• Study Type: Interventional
• Study Design: Not specified