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

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ClinicalTrials.gov Identifier: NCT03069079
Recruitment Status : Recruiting
First Posted : March 3, 2017
Last Update Posted : April 4, 2017
Sponsor:
Collaborator:
Great Ormond Street Hospital for Children NHS Foundation Trust
Information provided by (Responsible Party):
Queen Mary University of London

Brief 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.

Condition or disease Intervention/treatment Phase
Primary Immune Deficiency Disorder Periodontitis Procedure: Oral hygiene advice, non surgical periodontal treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation of Dental Health in Children With Neutrophil Defects: A Clinical Study
Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019


Arm Intervention/treatment
Experimental: Non surgical Periodontal therapy

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
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). .




Primary Outcome Measures :
  1. Probing pocket depth [ Time Frame: At baseline only (0 months) ]
    Measurement periodontal pocket depth at baseline (in millimetres, mm)

  2. Attachment level [ Time Frame: At baseline only (0 months) ]
    Measurement of attachment level at baseline (in millimetres, mm)

  3. Bleeding on probing [ Time Frame: At baseline only (0 months) ]
    Proportion of bleeding sites on probing at baseline (in percentage, %)

  4. Radiographic bone loss [ Time Frame: At baseline only (0 months) ]
    Proportion of bone loss in relation to total root length at baseline. (in percentage, %)

  5. Microbiological assay [ Time Frame: At baseline only (0 months) ]
    Microbiological analysis with next generation sequencing of the 16s rRNA metagenome at baseline. (Proportion of specified microbes present in sample at baseline)

  6. GCF [ Time Frame: At baseline only (0 months) ]
    Gingival crevicular fluid inflammatory markers (Proportion specified inflammatory markers present in sample at baseline)


Secondary Outcome Measures :
  1. Response to treatment: Probing pocket depth [ Time Frame: From baseline (0 months) to follow-up (24 months) ]
    Change in periodontal pocket depth at baseline to follow-up (in millimetres, mm)

  2. Response to treatment: Attachment level [ Time Frame: From baseline (0 months) to follow-up (24 months) ]
    Change in proportion of bleeding sites on probing at baseline to follow-up (in percentage, %)

  3. Response to treatment: Bleeding on probing [ Time Frame: From baseline (0 months) to follow-up (24 months) ]
    Change in proportion of bleeding sites on probing at baseline to follow-up (in percentage, %)

  4. Response to treatment: Microbiological assay [ Time Frame: From baseline (0 months) to follow-up (24 months) ]
    Change in proportion of specified microbes present in sample at baseline to follow-up

  5. Response to treatment: GCF [ Time Frame: From baseline (0 months) to follow-up (24 months) ]
    Change in proportion specified inflammatory markers present in sample at baseline to follow-up



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Ages Eligible for Study:   4 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

Each participant must meet the following inclusion criteria to be enrolled in the study:

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

    • Disorders of neutrophil numbers

      • Cyclic neutropenia
      • Congenital neutropenia
      • Severe Congenital Neutropoenia
      • X-linked Neutropoenia
    • Disorders of neutrophil function

      • Leucocyte Adhesion Defect s
      • Other neutrophil disorders/ undefined neutrophil disorders (functional defects demonstrated on testing but genetic basis not yet known)
    • Combined immunodeficiency syndromes

      • Wiskott Aldrich Syndrome
      • Hyper IgM Syndrome
      • Chediak Higashi Syndrome
      • Undefined combined immunodeficiency (functional defects demonstrated on testing but genetic basis not yet known)
  3. Participants/parents/guardians willing to sign the informed consent Exclusion Criteria Participants will not be eligible for participation in the study if unwilling to be examined or unable to return for follow-up appointments.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03069079


Contacts
Contact: Luigi Nibali, PhD l.nibali@qmul.ac.uk
Contact: Nikos Donos, PhD n.donos@qmul.ac.uk

Locations
United Kingdom
Center for Oral Clinical Research, Queen Mary, University of London Active, not recruiting
London, Greater London, United Kingdom, E1 2AD
Dental and Maxillofacial Department, Great Ormond Street Hospital for Children Recruiting
London, United Kingdom, WC1N 3JH
Contact: Carol Mason, BDS    020 7405 9200 ext 5289      
Sub-Investigator: Hiten Halai, BDS         
Sub-Investigator: Cheryl Somani, BDS         
Principal Investigator: Luigi Nibali, BDS MSC PHD         
Sponsors and Collaborators
Queen Mary University of London
Great Ormond Street Hospital for Children NHS Foundation Trust
Investigators
Principal Investigator: Luigi Nibali, PhD Queen Mary University of London

Responsible Party: Queen Mary University of London
ClinicalTrials.gov Identifier: NCT03069079     History of Changes
Other Study ID Numbers: COCR0004
011374 ( Registry Identifier: QMUL R and D )
15/LO/1090 ( Other Identifier: UK REC )
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: April 4, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Queen Mary University of London:
primary immunodeficiency
dental health
neutrophil defect
periodontitis

Additional relevant MeSH terms:
Periodontitis
Immunologic Deficiency Syndromes
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Immune System Diseases