Clinical trial NCT03401008: Buccodental Manifestations in Patients With Acromegaly
Official title: Descriptive Study of Buccodental Manifestations in a Group of Acromegalic Patients (AcroDent) Followed in the Endocrinology/Diabetology Service in the CHU of Clermont-Ferrand
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acromegaly
Keywords: Acromegaly
Oral manifestations
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: acromegalic patients

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: oral health of acromegal patients
timeFrame: at day 1 (during the odonto-stomatological consultation)
Secondary outcomes:
measure: study of the dental cementum
timeFrame: at day 2 (24h after receipt of sample)
measure: Determinate the CAO index
timeFrame: at day 2 (24h after receipt of sample)
measure: Analysis of pathological gingival tissues
timeFrame: at day 2 (24h after receipt of sample)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Igor TAUVERON
role: PRINCIPAL_INVESTIGATOR
References: