Buccodental Manifestations in Patients With Acromegaly

NCT03401008 | Unknown

• 1 other identifier: CHU-367
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Acromegaly

Keywords

Acromegaly; Oral manifestations

Outcome Measures

Primary Outcomes (1)

• oral health of acromegal patients

  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.

  at day 1 (during the odonto-stomatological consultation)

Secondary Outcomes (3)

• study of the dental cementum

  at day 2 (24h after receipt of sample)

• Determinate the CAO index

  at day 2 (24h after receipt of sample)

• Analysis of pathological gingival tissues

  at day 2 (24h after receipt of sample)

Study Arms (1)

Acromegalic patients

patients with a proven diagnosis of acromegaly achieved by an IGFA assay and a GH measure.

Other: Oral manifestations

Interventions

Oral manifestations OTHER

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.

Acromegalic patients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

acromegalic patients

You may qualify if:

• Adult acromegal patient followed in the endocrinology/diabetology service of the CHU of Clermont-Ferrand
• Proven diagnosis of acromegaly or previous acromegaly

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Conditions

Acromegaly; Oral Manifestations

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Igor TAUVERON

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

0473751195; placarin@chu-clermontferrand.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: January 17, 2018
• Study Start: December 15, 2016
• Primary Completion: December 30, 2018
• Study Completion: March 30, 2019
• Last Updated: January 17, 2018

Record last verified: 2018-01

Locations

FR (1)