A study to collect data of patients who were diagnosed with periodontal disease
| ISRCTN | ISRCTN17461473 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17461473 |
| Integrated Research Application System (IRAS) | 288321 |
| Protocol serial number | iT-06-2020 |
| Sponsor | University of Bristol |
| Funder | Align Technology |
- Submission date
- 18/08/2023
- Registration date
- 23/08/2023
- Last edited
- 05/09/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Patients with periodontitis suffer from gum recession whereby the gum moves down to expose more of the tooth and the tooth root. It is important to be able to measure gum recession accurately as it, together with a measurement of the pockets that develop around teeth which are affected by periodontitis, tells the dentist how badly affected the tooth is. This study is designed to collect data over a period of up to 2 years from patients that are diagnosed with periodontitis and receive treatment for it as part of standard care. Researchers want to see how well a 3D scan of the teeth and gums can track gum recession and recovery and compare the scans with the traditional ways in which these changes are measured and monitored in patient records such as by periodontal charting, radiographs, and intra-oral photos.
The main aim of this study is to track gum recession by standard measurements made by the clinician following a visual inspection of the teeth and using the images captured by the intra-oral 3D scanner in individuals with periodontitis throughout their course of periodontal therapy and maintenance. The researchers also want to examine the other changes that occur around the teeth such as bleeding and tooth mobility that are recorded as part of standard care.
Who can participate?
Adults aged 18 years and older with periodontal disease and a minimum of 20 of their own teeth
What does the study involve?
The study involves attending the dental clinic for the periodontal treatment that has been identified as part of standard dental care and for the associated supportive therapy appointments after the initial treatment. For the study, at these appointments scheduled as part of the standard clinical treatment for periodontal disease, the study team will use an intra-oral scanner to take a pictorial image of the mouth and measure the health of the gums using standard indices. Participants will be in the study for up to 2 years as their course of treatment/supportive therapy is completed.
What are the possible benefits and risks of participating?
There are no direct benefits for participants, but the information gained from the study may help improve the assessment of gum recession and recovery in patients in the future. There may be some minor discomfort during the scanning process, and very rarely a soft electric shock may be felt.
Where is the study run from?
Bristol Dental Hospital (UK)
When is the study starting and how long is it expected to run for?
June 2020 to September 2026
Who is funding the study?
Align Technology (USA)
Who is the main contact?
Prof. Nicola West, n.x.west@bristol.ac.uk
Contact information
Principal investigator
Bristol Dental Hospital
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
 ORCID ID |
0000-0002-9127-5530 |
|---|---|
| Phone | +44 (0)1173429503 |
| N.X.West@bristol.ac.uk |
Scientific
Bristol Dental Hospital and School
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
| Phone | +44 (0)1173429503 |
|---|---|
| Maria.davies@bristol.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre longitudinal case-control study |
| Secondary study design | Longitudinal case-control study |
| Study type | Participant information sheet |
| Scientific title | Periodontal patients 3D scan to track gingival recession |
| Study objectives | Gingival recession assessments measured from 3D scans will correlate with manual gingival recession measurements |
| Ethics approval(s) |
Approved 11/10/2021, Yorkshire & The Humber - Leeds East Research Ethics Committee (NHSBT Newcastle Blood Donor Centre Holland Drive, Newcastle upon Tyne, NE2 4NQ, United Kingdom; +44 (0)207 104 8141; leedseast.rec@hra.nhs.uk), ref: 21/YH/0201 |
| Health condition(s) or problem(s) studied | Diagnosis of extent of gingival recession in patients with periodontal disease |
| Intervention | There is no randomisation, all participants receive the same intervention, a 3D intra oral scan. Their gingivial recession will be measured manually and from the images captured on the scan. Participants will be in the study for up to 2 years, 3D scans being taken and their gingival recession measured manually and from the scan at their initial scheduled peridontal appointment and subsequent supportive therapy sessions. |
| Intervention type | Device |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | iTero Element 5D imaging system |
| Primary outcome measure(s) |
Gum recession: the distance between the cemento-enamel junction to the lowest point of the gingiva, measured in millimetres using a UNC-15 periodontal probe at each study visit, expected to be determined at baseline, 3, 6, 9, 12 and 24 months |
| Key secondary outcome measure(s) |
1. Pocket probing depth, measured in millimetres using a UNC-15 periodontal probe |
| Completion date | 30/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 50 |
| Total final enrolment | 50 |
| Key inclusion criteria | 1. Aged 18 years old and above with permanent teeth 2. Patients that are diagnosed with periodontal diseases (gingivitis, periodontitis) and are undergoing treatment to manage the condition 3. Have at least 20 natural teeth 4. Be willing and physically able to undergo all study procedures 5. Be willing and competent (verbally and cognitively) to give written informed consent |
| Key exclusion criteria | 1. Obvious signs of untreated caries, which in the opinion of the Study Dentist will affect the scientific validity of the study 2. Current orthodontic treatment 3. Participants who have been diagnosed with epilepsy 4. Current participation in any other clinical trials 5. Any participant who, in the reasonable judgement of the investigator, should not participate in the study 6. An immediate employee of the sponsor or the research team conducting the study. Employees of the Sponsor or research site not associated with the research team are eligible to participate |
| Date of first enrolment | 17/08/2022 |
| Date of final enrolment | 31/08/2023 |
Locations
Countries of recruitment
- United Kingdom
- England
- Wales
Study participating centre
Cardiff
CF14 6HB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in publicly available repository |
| IPD sharing plan | The anonymised participant data (clinical scores and questionnaire) generated during the current study will be shared once the data has been published and will be stored in the publicly available University of Bristol Research Data Repository (https://data.bris.ac.uk/data/) with a DOI maintained for a minimum of 20 years. Data will be made available as restricted access to bonafide researchers who provide a methodologically sound proposal and evidence of ethical approval (if required), subject to the agreement of the University of Bristol Data Access Committee for analysis to achieve aims in the approved proposal. Proposals will also be subject to the prior written consent of the funder. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/09/2025: The following changes were made to the study record:
1. The completion date was changed from 31/08/2025 to 30/09/2026.
2. The intention to publish date was changed from 30/04/2026 to 31/07/2027.
3. Total final enrolment added.
18/08/2023: Study's existence confirmed by the Yorkshire & The Humber - Leeds East Research Ethics Committee.
