Electrogustometric study of trigemino-gustatory interactions in humans

• Register: PACTR
• Last refreshed on: 29 May 2023
• Main ID: PACTR201602001452260
• Date of registration: 04/02/2016
• Prospective Registration: No
• Primary sponsor: Cheikh Anta Diop University and Hospitalo-University Center
• Public title: Electrogustometric study of trigemino-gustatory interactions in humans
• Scientific title: Trigemino-gustatory interactions: a randomized controlled clinical trial assessing the effects of selective anesthesia of trigeminal dental afferents on electrogustometric thresholds.
• Date of first enrolment: 05/12/2011
• Target sample size: 313
• Recruitment status: Complete
• URL: https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1452
• Study type: Interventional
• Study design: Parallel: different groups receive different interventions at same time during study,Randomised,Randomization in blocks of 4 patients (block size unknown to investigators),The allocation was kept in a sealed envelope until the completion of the study.
• Phase: Not Applicable

Countries of recruitment

Senegal

Contacts

• Name: Aichatou Sall
• Affiliation: Praticien/University

• Name: Babacar Touré
• Affiliation: Professor-researcher/University

Key inclusion & exclusion criteria

Inclusion criteria: age between 18 and 70, no significant health issues (i.e. absence of cardiovascular disease, systemic disease, chronic immunosuppression, hemophilia or asthma) and no current medication intake, non-smokers, restorative or Endodontic Treatment required on mandibular premolars or molars, no more than two missing teeth within the hemimandibula, no more than eight posterior teeth absent in total, no history of chronic orofacial pain for at least three weeks before the start of the study, no oral mucosal abnormality (ulceration, lichen planus etc.), no tongue piercing and agreement to sign an informed consent.
Exclusion criteria: Patients that do not fulfill the inclusion criteria, patients responding positively when EGM delivered no electrical current before anesthetic injection, patients presenting a lack of sensitivity in all loci before anesthetic injection or patients in which anesthesia was not effective after 30 minutes following injection.

Age minimum: 18 Year(s)
Age maximum: 70 Year(s)
Gender: Both

Health Condition(s) or Problem(s) studied

oral diseaes and physiology

oral diseaes and physiology

Intervention(s)

Dental anesthesia

Primary Outcome(s)

The main result of this randomized controlled clinical trial is a statistically significant increase in EGMt ipsilateral to the side (p<0.05) of the anaesthetized of the inferior alveolar nerve (IAN) (trigeminal) at dorsal and posterior sites of the tongue following anesthesia.

Secondary Outcome(s)

Secondary results were: a statistically significant increases in the EGMt ipsilateral to the side of the anesthetized mandibular nerve (MdN) in all the ipsilateral sites of the tongue following anesthesia and a lack of variation in the EGMt following maxillary anesthesia in any site of the tongue surface.

Secondary ID(s)

(# 0984).

# 0984

Source(s) of Monetary Support

Cheikh Anta Diop University

Secondary Sponsor(s)

Doctoral Scholl SEV

Ethics review

Status: Approved
Approval date: 09/12/2011
Contact:

the ethical committee of cheikh anta diop university

Status: Approved
Approval date: 23/12/2011
Contact:

the ethical committee of the Ministry of Health and Social Action of Senegal