Trials Sponsors Conditions Drugs Pricing

Conditions

Periodontitis Primary Immune Deficiency Disorder

Keywords

primary immunodeficiencydental healthneutrophil defectperiodontitis

Outcome Measures

Primary Outcomes (6)

Probing pocket depth
Measurement periodontal pocket depth at baseline (in millimetres, mm)
At baseline only (0 months)
Attachment level
Measurement of attachment level at baseline (in millimetres, mm)
At baseline only (0 months)
Bleeding on probing
Proportion of bleeding sites on probing at baseline (in percentage, %)
At baseline only (0 months)
Radiographic bone loss
Proportion of bone loss in relation to total root length at baseline. (in percentage, %)
At baseline only (0 months)

Secondary Outcomes (5)

Response to treatment: Probing pocket depth
From baseline (0 months) to follow-up (24 months)
Response to treatment: Attachment level
From baseline (0 months) to follow-up (24 months)
Response to treatment: Bleeding on probing
From baseline (0 months) to follow-up (24 months)
Response to treatment: Microbiological assay
From baseline (0 months) to follow-up (24 months)
Response to treatment: GCF
From baseline (0 months) to follow-up (24 months)

Study Arms (1)

Non surgical Periodontal therapy

EXPERIMENTAL

All children will be offered an oral hygiene and tooth scaling and polishing session. For children affected by periodontal disease, subgingival debridement will also be performed according to needs, with the aim to disrupt the subgingival biofilm responsible for the onset and progression of the periodontal pathology. This can be accompanied, when appropriate, by the use of local anaesthesia and adjunctive antimicrobials (systemic or locally applied subgingivally), according to the clinical presentation and the child's medical conditions. In addition, when required, nitrous oxide sedation (NOS) could be used before treatment. Caries will be treated as necessary (shared care with the general dental practitioners / community dental services). Children with mucosal lesions requiring treatment will be given a letter for their GDP suggesting referral to a collaborating expert in Oral Medicine (Prof. Stephen Porter).

Procedure: Oral hygiene advice, non surgical periodontal treatment

Interventions

Oral hygiene advice, non surgical periodontal treatmentProcedure

For children affected by periodontal disease, oral hygiene advice, non surgical periodontal treatment will also be performed according to needs. This can be accompanied, when appropriate, by the use of local anaesthesia and adjunctive antimicrobials (systemic or locally applied subgingivally), according to the clinical presentation and the child's medical conditions. Accurate supra- and sub-gingival removal of calculus and dental plaque will be performed both with ultrasonic and/or manual instruments. The necessary sub-gingival debridement will be performed in 1 to 4 visits (either full mouth treatment, half-mouth treatment or quadrant-wise treatment) depending on patient preference and practical considerations, using manual (Gracey curettes, Hu-Friedy) and ultrasonic devices (EMS). .

Non surgical Periodontal therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age4 Years - 16 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Age 4-16 years
Diagnosis of one of the following neutrophil defects (as confirmed by the treating physician):

Sponsors & Collaborators

Great Ormond Street Hospital for Children NHS Foundation Trust
Othercollaborator
Queen Mary University of London
Otherlead

Study Sites (2)

Center for Oral Clinical Research, Queen Mary, University of London

London, Greater London, E1 2AD, United Kingdom

Dental and Maxillofacial Department, Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

MeSH Terms

Conditions

Primary Immunodeficiency DiseasesPeriodontitis

Condition Hierarchy (Ancestors)

Genetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesImmunologic Deficiency SyndromesImmune System DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

Luigi Nibali, PhD
Queen Mary University of London
PRINCIPAL INVESTIGATOR

Enrollment

50 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 17, 2017

First Posted

March 3, 2017

Study Start

December 2016

Date type not reported

This date has not been verified as actual or estimated.

Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (5)

Study Arms (1)

Non surgical Periodontal therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (6)

Secondary Outcomes (5)

Study Arms (1)

Non surgical Periodontal therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Data Sharing

Source record

Locations