Self-perceived impacts on daily living after periodontal treatment in a Brazilian elderly population.

ISRCTN	ISRCTN78075532
DOI	https://doi.org/10.1186/ISRCTN78075532
Secondary identifying numbers	N/A

Submission date: 24/07/2015
Registration date: 21/08/2015
Last edited: 11/08/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Background and study aims
Periodontitis (PD) is a very common chronic gum infection that damages the soft tissue and destroys the bone supporting the teeth. It can lead to tooth loss, difficulties chewing, poor appearance of teeth and gums and it can even increase the risk of a heart attack or stroke. It is caused by the build-up of bacteria in the mouth which, over time, combines with saliva and small food particles to form a sticky film over the teeth, called plaque. The bacteria in the plaque can result in gum disease, leading to swollen, painful gums. If not treated, this gum disease will get worse and will develop into periodontitis. This study investigates how elderly people think their quality of life has been affected by having treatment for their periodontitis, taking into account physical, psychological, social and environmental aspects as well as individual belief (OMS). The patients with chronic periodontal disease may experience emotional changes that can affect their daily life. The aim of this study was to compare these effects on daily living in an elderly Brazilian population after they have had periodontal treatment.

Who can participate?
Adults older than 60 with periodontal disease.

What does the study involve?
All participants have an initial periodontal clinical examination and have their quality of life (as affected by their oral health) assessed by them answering a set of questions and completing a questionnaire. They are then randomly allocated into one of two groups. Those in group 1 (test group) are given conventional non-surgical periodontal treatment that includes scaling and root planing along with oral hygiene instructions. Those in group 2 (control group) are not given the treatment at this time. Both groups of participants are then invited back for a second clinical examination and quality of life assessment 30 days after the start of the study and after the test group participants have had their treatment. Finally, the participants in the control group are offered the same non-surgical periodontal treatment once the study is complete.

What are the possible benefits and risks of participating?
There is no immediate direct benefit to those taking part. However, there should be benefits to research related to periodontal health and quality of life in an elderly population. There are no risks to participating because patients are treated with conventional non-surgical periodontal treatment.

Where is the study run from?
Department of Dental Clinics, Division of Graduate Periodontics, Federal University of Rio de Janeiro (Brazil)

When is the study starting and how long is it expected to run for?
July 2004 to March 2005

Who is funding the study?
Federal University of Rio de Janeiro (Brazil)

Who is the main contact?
1. Mrs Flávia Santos
2. Mrs Anna Leão

Contact information

Mrs Flávia Santos
Scientific

Federal University of Rio de Janeiro
Department of Dental Clinics
Division of Graduate Periodontics
Niterói, RJ
24220-121
Brazil

Mrs Anna Leão
Scientific

Rio de Janeiro Federal University
Av . Carlos Chagas Filho 373
CCS building block K, 2nd floor
Room 56, University City Island
Rio de Janeiro
21.941-902
Brazil

Study information

Study design	Interventional single-centre study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	Self-perceived impacts on daily living in an elderly population regarding periodontal treatment.
Study objectives	The periodontal treatment does not cause impacts on the daily living of an elderly Brazilian population.
Ethics approval(s)	Clementino Fraga Filho University Hospital Human Research Commitee, Federal University of Rio de Janeiro (UFRJ) - RJ, Brazil, 01/07/2004, ref: 089/04
Health condition(s) or problem(s) studied	Periodontal disease
Intervention	A sample of 53 patients aged over 60 were randomly allocated into one of 2 groups: control or test. Participants in both groups had a periodontal clinical examination and had their oral health impact on their quality of life assessed by a set of 22 questions (PHQ-QoL) and through completing a questionnnaire (OHIP-14) at baseline and then after the test group have had the therapy described below. Participants in the control group received the same therapy after the study was complete. Therapy: full-mouth scaling and root planing.
Intervention type	Other
Primary outcome measure	1. PHQ-QoL - a set of 22 questions related to gingival bleeding, halitosis, sensitivity, aesthetics dissatisfaction, eating and social restriction 2. OHIP-14 questionnaire, assessing quality of life. Measurements were taken at baseline and after the periodontal treatment period
Secondary outcome measures	1. Probing pocket depth 2. Clinical attachment level 3. Visible plaque 4. Bleeding on probing 5. Tooth mobility 6. Number of Teeth Measured at baseline and after the periodontal treatment period
Overall study start date	22/07/2004
Completion date	30/03/2005

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	53 patients (27 in control group and 26 in test group)
Key inclusion criteria	1. Patients older than 60 2. Males or females 3. At the minimum of 15 teeth 4. At least 1 site with pocket depth >5 mm 5. Two teeth with clinical attachment level > 6 mm at baseline
Key exclusion criteria	1. Total edentulism 2. Presence of acute periodontal diseases 3. Neurologic and auditive problems
Date of first enrolment	22/07/2004
Date of final enrolment	30/01/2005

Locations

Countries of recruitment

Brazil

Study participating centre

Department of Dental Clinics

Division of Graduate Periodontics
Federal University of Rio de Janeiro
Rio de Janeiro
21.941-902
Brazil

Sponsor information

Federal University of Rio de Janeiro
University/education

Department of Dental Clinics
Division of Graduate Periodontics
Rio de Janeiro
21.941-902
Brazil

Website	www.odontologia.ufrj.br
"ROR"	https://ror.org/03490as77

Funders

Funder type

Not defined

Investigator initiated and funded (Brazil)

No information available

Results and Publications

Intention to publish date	01/12/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	I intend to publish this study in an international journal related to dental hygiene, prevention and quality of life in 2015.
IPD sharing plan