Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
13/03/2014
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

Dr GS Griffiths

ORCID ID

Contact details

Periodontology
Periodontology Department
Eastman Dental Institute
256 Gray`s Inn Road
London
WC1X 8LD
United Kingdom
+44 (0)20 7 915 1074

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0263156056

Study information

Scientific title

Acronym

Study hypothesis

To explore the clinical and molecular outcome of two surgical treatments (regeneration and repair) for the management of intrabony defects will be compared in patients with aggressive periodontitis.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Periodontitis

Intervention

1. Group A: regeneration treatment
2. Group B: repair treatment

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

The main clinical outcome variables will be Lifetime Cumulative Attachment Loss (LCAL) and level of bone loss. The main laboratory outcome variables will be change in level of specific growth factors (Platelet-Derived Growth Factor [PDGF], Vascular Endothelial Growth Factor [VEGF], Transforming Growth Factor beta [TGFb]), Bone Morphogenetic Protein [BMP] and osteoprotegerin.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

12/01/2005

Overall trial end date

01/07/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Not provided at time of registration

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

30 patients from Periodontology

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

12/01/2005

Recruitment end date

01/07/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Periodontology
London
WC1X 8LD
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

UCL Hospitals NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes