Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001452260 Date of Approval: 04/02/2016
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Electrogustometric study of trigemino-gustatory interactions in humans
Official scientific title Trigemino-gustatory interactions: a randomized controlled clinical trial assessing the effects of selective anesthesia of trigeminal dental afferents on electrogustometric thresholds.
Brief summary describing the background and objectives of the trial Peripheral gustatory information is mainly captured by facial glossorpharyngeal and vagus cranial nerves but also by the trigeminal nerve. Animal studies have shown that dental afferents innervated by the third division of the trigeminal nerve might contribute to the overall sensation of taste. Regarding the prevalence of dental treatments leading to the loss of dental innervation and its possible consequence on food intake, it is of importance to evaluate the contribution of dental afferences to taste sensation. The objective of this single blinded clinical study was to analyze the effect of the temporary removal of trigeminal dental afferents stimulation on electrogustometric thresholds (EGMt). EGMt were measured in 300 healthy subjects randomized in 3 groups, in 9 loci of the tongue surface before (T0) and after anesthesia (T1). Group LRA-MdN received loco-regional anesthesia (LRA) of the mandibular nerve (MdN) (n=60, right side (RS) and n=40 left side, LS); group LA-IAN (n=56 RS, n=44 LS) received intraosseous local anesthesia (LA) of the inferior alveolar nerve (IAN). Group LA-MxN which received local anesthesia (LA) of the palatal and retro-tuberosity maxillary nerve (MxN) (n=56 RS and n=44 LS) was the control group.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) TEETHTASTE.
Disease(s) or condition(s) being studied oral diseaes and physiology
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 05/12/2011
Actual trial start date 09/01/2012
Anticipated date of last follow up 27/11/2014
Actual Last follow-up date 28/02/2015
Anticipated target sample size (number of participants) 313
Actual target sample size (number of participants) 300
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
# 0984 Ministry of Health and Social Action of Senegal
(# 0984). the ethical committee of the Ministry of Health and Social Action of Senegal
# 0984 Ministry of Health and Social Action of Senegal
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
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. Masking/blinding used
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. Masking/blinding used
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. Masking/blinding used
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. Masking/blinding used Care giver/Provider,Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Dental anesthesia 2% lidocaine and epinephrine 1/100.000 contained in 1.8 ml carpules 20-30 mn Loco-regional anesthesia of mandibular nerve (LRA-MdN) 100
Control Group Dental anesthesia 2% lidocaine and epinephrine 1/100.000 contained in 1.8 ml carpules 20-30 mn Local anesthesia of maxillary nerve (LA-MxN) 100 Active-Treatment of Control Group
Experimental Group Dental anesthesia 2% lidocaine and epinephrine 1/100.000 contained in 1.8 ml carpules 20-30 mn Local anesthesia of inferior alveolar nerve (LA-IAN) 100
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 23/12/2011 the ethical committee of the Ministry of Health and Social Action of Senegal
Ethics Committee Address
Street address City Postal code Country
Fann Résidence, Rue Aimé Césaire Dakar Senegal
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 09/12/2011 the ethical committee of cheikh anta diop university
Ethics Committee Address
Street address City Postal code Country
avenue cheikh diop dakar fann Dakar Fax: 33 825 29 52 Senegal
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome 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. Stade T0 Before anesthesia Stade T1 After Anesthesia
Secondary Outcome 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. Stade T0 Before anesthesia Stade T1 After Anesthesia
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
the Abdoul Aziz Sy Dabakh dental clinic Khourounar city of Pikine, Senegal Pikine Senegal
the dental clinic of Anta Diop University Avenue Cheikh Anta Diop, Dakar Fann Dakar BP 5005 Senegal
Newtown dental clinic Liberte 6 extension of Dakar, Senegal Dakar No Senegal
FUNDING SOURCES
Name of source Street address City Postal code Country
Cheikh Anta Diop University Avenue Cheikh Anta Diop, Dakar Fann daker BP 5005 Senegal
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Cheikh Anta Diop University and Hospitalo-University Center Avenue Cheikh Anta Diop, Dakar Fann Dakar BP 5005 Senegal University
Secondary Sponsor Doctoral Scholl SEV Cheikh Anta Diop University, Department statistics Dakar BP 5005 Senegal University
COLLABORATORS
Name Street address City Postal code Country
Pr Babacar Touré Dentistry and Medecine Faculty of Cheikh Diop University Dakar BP 5005 Senegal
Pr Yves BOUCHER UFR Odontologie & Centre de Psychiatrie et Neurosciences 5 Rue Garancière 75006 Paris Paris 75006, Paris France
Papa Abdou Lecor Dentistry and Medecine Faculty of Cheikh Anta Diop University Dakar BP 5005 Senegal
Assion Lawson Cheikh Anta Diop University, Department statistics Dakar Senegal
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Papa Abdou Lecor papalecorchdent@yahoo.fr 00221772145250 Dentistry and Medecine Faculty of Cheikh anta diop university
City Postal code Country Position/Affiliation
dakar BP 5005 Senegal Professor-researcher/University
Role Name Email Phone Street address
Public Enquiries Aichatou Sall dadychdent@orange.sn 00221778161974 Dentistry and Medecine Faculty of Cheikh anta diop university
City Postal code Country Position/Affiliation
BP 5005 Senegal Praticien/University
Role Name Email Phone Street address
Scientific Enquiries Babacar Touré btoure99@yahoo.fr 002216485181 Dentistry and Medecine Faculty of Cheikh anta diop university
City Postal code Country Position/Affiliation
dakar BP 5005 Senegal Professor-researcher/University
REPORTING
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