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

NCT03069079 | Completed

• 3 other identifiers: COCR000401137415/LO/1090
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Primary Immune Deficiency Disorder; Periodontitis

Keywords

primary immunodeficiency; dental health; neutrophil defect; periodontitis

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)

• Microbiological assay

  Microbiological analysis with next generation sequencing of the 16s rRNA metagenome at baseline. (Proportion of specified microbes present in sample at baseline)

  At baseline only (0 months)

• GCF

  Gingival crevicular fluid inflammatory markers (Proportion specified inflammatory markers present in sample at baseline)

  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 treatment PROCEDURE

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

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 4-16 years
• 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)

Sponsors & Collaborators

• Queen Mary University of London: lead
• Great Ormond Street Hospital for Children NHS Foundation Trust: collaborator

Study Sites (2)

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

London, Greater London, E1 2AD, United Kingdom

Location

Dental and Maxillofacial Department, Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

Location

MeSH Terms

Conditions

Primary Immunodeficiency Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Luigi Nibali, PhD

  Queen Mary University of London

  PRINCIPAL INVESTIGATOR

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 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: December 1, 2019
• Last Updated: November 14, 2022

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)