Condition category
Oral Health
Date applied
24/07/2015
Date assigned
21/08/2015
Last edited
11/08/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Flávia Santos

ORCID ID

Contact details

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

Type

Scientific

Additional contact

Mrs Anna Leão

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Self-perceived impacts on daily living in an elderly population regarding periodontal treatment.

Acronym

Study hypothesis

The periodontal treatment does not cause impacts on the daily living of an elderly Brazilian population.

Ethics approval

Clementino Fraga Filho University Hospital Human Research Commitee, Federal University of Rio de Janeiro (UFRJ) - RJ, Brazil, 01/07/2004, ref: 089/04

Study design

Interventional single-centre study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

22/07/2004

Overall trial end date

30/03/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

53 patients (27 in control group and 26 in test group)

Participant exclusion criteria

1. Total edentulism
2. Presence of acute periodontal diseases
3. Neurologic and auditive problems

Recruitment start date

22/07/2004

Recruitment end date

30/01/2005

Locations

Countries of recruitment

Brazil

Trial 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

Organisation

Federal University of Rio de Janeiro

Sponsor details

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

Sponsor type

University/education

Website

www.odontologia.ufrj.br

Funders

Funder type

Not defined

Funder name

Investigator initiated and funded (Brazil)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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.

Intention to publish date

01/12/2015

Participant level data

Other

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes