Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Periodontitis
Intervention
1. Group A: regeneration treatment
2. Group B: repair treatment
Intervention type
Other
Primary outcome measure
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 study start date
12/01/2005
Overall study end date
01/07/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type(s)
Patient
Age group
Not Specified
Sex
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
England, United Kingdom
Study 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
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|