Condition category
Oral Health
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
06/01/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jane Rooney

ORCID ID

Contact details

University of Bristol
Dental Hospital and School
Lower Maudlin Street
Bristol
BS1 2LY
United Kingdom
+44 (0)117 9294472
J.C.Rooney@bristol.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

R/ROONEY/291

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study is to evaluate systematic metronidazole and amoxycillin, alone and combined, as adjuncts to root planning in the treatment of patients with severe adult periodontis. In addition, microbiological monitoring will be performed in order to determine of pre-treatment microbiological status influences treatment outcome.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Oral health/stomatognathic diseases: Severe periodontal disease

Intervention

Not provided at time of registration

Intervention type

Drug

Phase

Not Specified

Drug names

metronidazole and amoxycillin

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/1994

Overall trial end date

01/06/1997

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Added 06/01/10: 66

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/1994

Recruitment end date

01/06/1997

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Bristol
Bristol
BS1 2LY
United Kingdom

Sponsor information

Organisation

NHS R&D Regional Programme Register - Department of Health (UK)

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South West (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/11966932

Publication citations

  1. Results

    Rooney J, Wade WG, Sprague SV, Newcombe RG, Addy M, Adjunctive effects to non-surgical periodontal therapy of systemic metronidazole and amoxycillin alone and combined. A placebo controlled study., J. Clin. Periodontol., 2002, 29, 4, 342-350.

Additional files

Editorial Notes