Orthodontic treatment in patients with stable reduced periodontium. V1
Research type
Research Study
Full title
A randomised trial assessing recurrence of periodontal disease during orthodontic treatment in patients following successful periodontal treatment.
IRAS ID
299758
Contact name
Luigi Nibali
Contact email
Sponsor organisation
Vice President & Vice Principal (Research). King's College London
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
1 years, 11 months, 29 days
Research summary
Irreversible gum disease (periodontitis) is an inflammatory condition leading to loss of supporting tissue (bone and gums) around the teeth affected. This could result in teeth becoming mobile and drifting apart. The effects of periodontal disease often lead to loss of confidence when smiling as well as reduced function (such as chewing). Loss of teeth could also lead to complex treatment planning. Patients who have a history of gum disease are at risk of relapse (recurrence of the disease).
In this study, we aim to assess if straightening the teeth (orthodontics) in patients with misalignement and previous history of gum disease can affect the stability of the gum condition, whilst having regular supportive periodontal care (SPC). The study involves comparing this group (test) to a group of patients who only have regular SPC (control). The patients eligible for the study (over age of 20) will be randomised in either test or control. Both groups will have a cone beam computed tomography (CBCT) scan of their teeth and bone to assess the bone levels and assist in treatment planning. They will also have a digital scan of their teeth to look at the soft tissues and gums and assess any changes during the study. A final CBCT of both groups will be taken to compare any changes in the bone levels. The control group will be offered alignment of their teeth once the study is terminated. Each participant will be in the study for approximately 18 months.
Microbiological plaque bacteria and samples of saliva and gingival crevicular fluid from test and control sites will be collected. Self-reported questionnaires will be completed to provide information on participants' attitudes to their teeth and treatment. Data will be analysed and a report will be submitted 12 months after last patient last visit.REC name
London - South East Research Ethics Committee
REC reference
23/LO/0034
Date of REC Opinion
2 Mar 2023
REC opinion
Further Information Favourable Opinion