- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03401008
Buccodental Manifestations in Patients With Acromegaly (AcroDent)
Descriptive Study of Buccodental Manifestations in a Group of Acromegalic Patients (AcroDent) Followed in the Endocrinology/Diabetology Service in the CHU of Clermont-Ferrand
Context: Acromegaly is the rare condition (3 to 4 new cases per million per year) due to Growth Hormone (GH) overproduction by a somatotrope pituitary adenoma, resulting in Insulin Growth Factor 1 (IGF-1) excess. Consequently, many tissues of the organism become hypertrophied. Hypertrophy of gingival and dental tissues can lead to alteration of oral health. However, there are very few published data concerning oral impact of acromegaly.
Objective: To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand.
Study Overview
Detailed Description
Context/ study relevance: Acromegaly is a rare condition (3 to 4 new cases per million per year) due to Growth Hormone (GH) overproduction by a somatotrope pituitary adenoma, resulting in Insulin Growth Factor 1 (IGF-1) excess. Consequently, a dysmorphic syndrome prevailing at the level of face and extremities progressively develops associated with potentially severe general manifestations (cardiovascular, respiratory and metabolic complications). Oral manifestations of acromegaly are not well known, there is very few published data on this topic and a controversy about the existence of a parodontal disease, i.e. the presence of gingival sulcus deepening which can lead to tooth loss. IGF-1 excess could lead to gingival hypertrophy and then to gingival sulcus deepening. Otherwise, the dental cementum, the only dental tissue which can grow during all lifetime, could be influenced by an excess of IGF-1. It is likely that acromegaly is associated with pathological cementum hypertrophy.
Objective: To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand. Investigator will take a special interest in parodontal status i.e. the state of supporting tissues of the teeth and structural anomalies of dental cementum.
As secondary objective, investigator would make a histological characterization of gingival and dental (cementum) tissues when a surgical treatment of the oral condition is required. Investigator will search hypertrophic anomalies linked with GH/IGF-1 excess.
Material and methods: This is an observational, descriptive, cross-sectional, monocentric study conducted in the endocrinology/diabetology service of Clermont-Ferrand University Hospital (CHU), in France, where a series of about 70 prevalent acromegaly patients is annually followed. The participants will be adult acromegaly patients followed in this service, with proven diagnosis of acromegaly or previous acromegaly. They will be excluded of the study if they are totally toothless, if they take a medication associated with gingival hypertrophy if they are in a medical or chirurgical condition interacting with oral health so that the oral evaluation is not reliable or if there is no possibility of written informed consent. For each participant, investigator will collect demographic data and history of the pathology including previous and actual complications, biological tests results, imaging exams results and treatments. The participants will answer 3 questionnaires: AcroQol (quality of life in acromegaly patients), GOHAI (General Oral Health Assessment Index) and EPICES (evaluation of precariousness). The primary outcome will be a quantitative assessment of the oral health of the acromegalic patients with detailed assessment of 3 criteria:
- Depth of gingival sulcus measured for of all teeth
- CAO index (number of teeth with cavity or obturation or missing)
- Thickness of dental cementum on orthopantomogram and all other abnormality on this exam.
The secondary outcome will be the histological analysis of gingival and dental tissues if available.
All these measures will be taken during a routine odonto-stomatological consultation, part of the annual pathology evaluation at the endocrinology/diabetology service.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
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Principal Investigator:
- Igor TAUVERON
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult acromegal patient followed in the endocrinology/diabetology service of the CHU of Clermont-Ferrand
- Proven diagnosis of acromegaly or previous acromegaly
Exclusion Criteria:
- Minor subject
- Subject under guardianship or curatorship
- Total toothless patients
- No possibility of written informed consent
- Medical or chirurgical conditions interacting with oral health so that the oral evaluation is not reliable
- Medication associated with gingival hypertrophy
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Acromegalic patients
patients with a proven diagnosis of acromegaly achieved by an IGFA assay and a GH measure.
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To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
oral health of acromegal patients
Time Frame: at day 1 (during the odonto-stomatological consultation)
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the periodontal status would be determinate by measuring the depth of gingival sulcus with a graduated periodontal probe on the four dental faces (mesial, distal, vestibular and lingual), on each tooth present in the mouth.
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at day 1 (during the odonto-stomatological consultation)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
study of the dental cementum
Time Frame: at day 2 (24h after receipt of sample)
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the thickness of dental cementum would be measured on orthopantomogram.
This characteristic could determinate the presence or not of hypercementosis
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at day 2 (24h after receipt of sample)
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Determinate the CAO index
Time Frame: at day 2 (24h after receipt of sample)
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The CAO index could be determinate by counting the number of teeth with cavity or obturation or missing
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at day 2 (24h after receipt of sample)
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Analysis of pathological gingival tissues
Time Frame: at day 2 (24h after receipt of sample)
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: if a gingival hypertrophy is determinate, a gingivectomy will be carried out and the tissue will be sent to the Anatomo-pathology laboratory to determinate its histological characteristics
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at day 2 (24h after receipt of sample)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-367
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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