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AcromegalyAcroDentNCT03401008

Buccodental Manifestations in Patients With Acromegaly

An observational study of Acromegaly, run by University Hospital, Clermont-Ferrand at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Acromegaly
What is being tested?
Oral manifestations
Type of treatment
Pill or oral medicine
How many people
70 participants
Where
1 siteFrance
Study dates
15 Dec 2016to 30 Mar 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: acromegalic patients

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site, 1 recruiting
  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003

    Patrick LACARIN, 0473751195, placarin@chu-clermontferrand.fr

    Igor TAUVERON

    Recruiting

Other trials in France

About this study

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

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.

Read the 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.

Conditions
Acromegaly
Being tested
Oral manifestations
Keywords
Acromegaly, Oral manifestations
Medical subject headings
Acromegaly, Oral Manifestations

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oral manifestationsOther

    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 groups in NCT03401008
Study groupRoleWhat they receive
Acromegalic patientspatients with a proven diagnosis of acromegaly achieved by an IGFA assay and a GH measure.
Receives: Other: Oral manifestations

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: at day 1 (during the odonto-stomatological consultation)

Secondary outcomes (3)
  1. study of the dental cementum

    the thickness of dental cementum would be measured on orthopantomogram. This characteristic could determinate the presence or not of hypercementosis

    Measured: at day 2 (24h after receipt of sample)

  2. Determinate the CAO index

    The CAO index could be determinate by counting the number of teeth with cavity or obturation or missing

    Measured: at day 2 (24h after receipt of sample)

  3. Analysis of pathological gingival tissues

    : 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

    Measured: at day 2 (24h after receipt of sample)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start15 Dec 2016
  3. Primary completion30 Dec 2018 (estimated)
  4. Study completion30 Mar 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03401008
Sponsor's protocol ID
CHU-367
Acronym
AcroDent
Status last verified
Jan 2018
First submitted
20 Nov 2017
Last updated
17 Jan 2018
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Acromegaly, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Patrick LACARIN (0473751195, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

oral health of acromegal patients (time frame: at day 1 (during the odonto-stomatological consultation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2018.

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