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

Summary

Title: Investigation of neutrophil defects associated with periodontal disease and tooth loss in children. A clinical study.

Objectives: The primary objective of this study is:

* To investigate presence of periodontal disease and response to periodontal treatment in children affected by neutrophil defects

The secondary objectives of this study are:

* To investigate presence of other dental diseases in children affected by neutrophil defects
* To assess oral microbiological and inflammatory parameters in children affected by neutrophil defects

Primary outcomes: The primary outcomes are (a) presence of periodontal disease as assessed by clinical factors: probing pocket depth, attachment level, bleeding on probing and radiographic bone loss) (b) microbiological and host response factors: detected in periodontal pockets and gingival crevicular fluid and (c) response to treatment

Study sample: Children affected by neutrophil defects and meeting outlined inclusion and exclusion criteria

Number of participants: 50 children

Study design: This is a longitudinal treatment study. All participants will attend for 4-7 visits during the study as outlined below:

* Screening visit (visit 1): consent procedure, dental examination, saliva and plaque sampling
* Baseline visit (visit 2):, detailed periodontal examination, dental radiographs, sampling of gingival crevicular fluid and, if appropriate scaling, polishing and oral hygiene instructions
* Non-surgical periodontal treatment (visit 3A to 3D, max 4 sessions): oral hygiene instructions and supra- and sub-gingival debridement (under local anaesthesia if necessary)
* Follow-up Visit (visit 4, 4th to 7th visit) (six months following treatment): detailed dental examination, oral hygiene instructions, sampling of saliva, subgingival plaque and gingival crevicular fluid, tooth scaling and polishing.

Conditions

• Primary Immune Deficiency Disorder
• Periodontitis

Interventions

PROCEDURE

Oral hygiene advice, non surgical periodontal treatment

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). .

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust

  collaborator OTHER

• Queen Mary University of London

  lead OTHER

Principal Investigators

• Luigi Nibali, PhD · Queen Mary University of London

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

4 Years

Max Age

16 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-31

Primary Completion

2018-12-31

Completion

2019-12-31

Countries

• United Kingdom

Study Locations