Botulinum Toxin Injections for Oral Neuropathic Pain (TRIGTOX)
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ClinicalTrials.gov Identifier: NCT03555916 |
Recruitment Status :
Recruiting
First Posted : June 14, 2018
Last Update Posted : November 9, 2020
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Condition or disease | Intervention/treatment | Phase |
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Trigeminal Neuropathy, Traumatic | Drug: BOTOX®, Allergan Drug: Placebo | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Masking Description: | Double Blind |
Primary Purpose: | Treatment |
Official Title: | Use of Botulinum Toxin (BTX) for the Treatment of Peripheral Painful Traumatic Trigeminal Neuropathy (PPTTN) |
Actual Study Start Date : | April 4, 2019 |
Estimated Primary Completion Date : | November 2022 |
Estimated Study Completion Date : | April 2023 |
Arm | Intervention/treatment |
---|---|
Experimental: Drug
BOTOX®, Allergan treatment in 2 mL of saline solution (0.9% NaCl) treatment
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Drug: BOTOX®, Allergan
50 U BTX-A (BOTOX®, Allergan) powder diluted in 2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection
Other Name: BOTOX |
Placebo Comparator: Placebo
2 mL of saline solution (0.9% NaCl) treatment
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Drug: Placebo
2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection |
- Change from baseline of self-reported average pain intensity using 11-point numerical scale (0 = no pain; 10 = maximal pain imaginable) at one month [ Time Frame: before and one month after injection ]Self-reported average pain intensity from each morning's record in a diary concerning the last 24 hours during one week, before and one month after injection
- Pain measurement with the 11-point numerical scale of the Brief Pain Inventory (BPI) [ Time Frame: At baseline, 1, 3 and 6 months ]Pain recorded each morning in a diary (diary 2) concerning the last 24 hours, using the 11-point numerical scale (NS; 0 = no pain; 10 = maximal pain imaginable) of the Brief Pain Inventory (BPI) at 1 month, 3 months and 6 months. The least, average, and maximum pain intensity during the 7 days will be collected and compared to baseline.
- Pain measurement with the neuropathic pain symptom inventory (NPSI) [ Time Frame: At baseline, 1, 3 and 6 months ]Items of the neuropathic pain symptom inventory (NPSI) will be recorded during the last 24 hours on 11-points (0-10 points) numerical scales.
- Pain measurement with Visual Analogic Scale (VAS) [ Time Frame: At baseline, 1, 3 and 6 months ]Visual Analogic Scale (VAS) (from 0 mm [no pain relief] to 100 mm [maximal pain relief]).
- Pain measurements with Clinical Global Impression - Improvement scale (CGI-I) [ Time Frame: At baseline, 1, 3 and 6 months ]The Clinical Global Impression - Improvement scale (CGI-I) (a 7-point scale rating from very much improved to very much worse) will be used .
- Areas of pain [ Time Frame: At baseline, 1, 3 and 6 months ]The areas of main pain and referred pain will be reported directly from the patient to a soft foil, then digitized for measurement on Image J software.
- Assessment of sensory deficit according to intraoral Quantitative Sensory Testing (QST) [ Time Frame: At baseline, 1, 3 and 6 months ]
According to the conclusions of the European task force committee for intraoral quantitative sensory testing (QST), the QST is defined by :
- Brush-induced allodynia will be evaluated stroking the skin with a standardized brush and will be considered as present if evoking a clear sensation of pain. The intensity of allodynia will be recorded on a 100 mm visual analog scale. Area of Brush-induced allodynia will be traced on a transparent plastic foil, and then digitized for measurement on Image J software.
- Mechanical sensations (detection thresholds to non-painful stimuli) and pain thresholds will be measured with calibrated von Frey hairs (0.06-300gm) (Bioseb, France) (or electronic von Frey, Bioseb France).
- Thermal sensations and pain thresholds (in °C) will be assessed with a thermoalgometer (TSA II; Medoc, Israel) with an intraoral thermode by the method of limits, with baseline temperatures adjusted to the patient's skin temperature .
- Emotional state with Hospital Anxiety and Depression Scale (HADS) [ Time Frame: At baseline, 1, 3 and 6 months ]Emotional state using the Hospital Anxiety and Depression Scale (HADS) including 14 items scored as anxiety and depression scores (each on 21)
- Emotional state with Brief Pain Inventory (BPI). [ Time Frame: At baseline, 1, 3 and 6 months ]Emotional state using items of the Brief Pain Inventory (BPI).
- Movement and function [ Time Frame: At baseline, 1, 3 and 6 months ]Interference with oral function will be measured with the Brief Pain Inventory (BPI) (with the exclusion of the item "ability to walk" changed for "ability to chew" judged more relevant here) rated from 0 (does not interfere) to 10 (complete interference).
- Quality of life with Geriatric Oral Health Assessment Index (GOHAI) [ Time Frame: At baseline, 1, 3 and 6 months ]Quality of life will be assessed with specific questionnaires Geriatric Oral Health Assessment Index (GOHAI)
- Quality of life with Oral Health Impact Profile (OHIP) [ Time Frame: At baseline, 1, 3 and 6 months ]Quality of life will be assessed with specific Oral Health Impact Profile (OHIP)
- Quality of life with items of Brief Pain Inventory (BPI). [ Time Frame: At baseline, 1, 3 and 6 months ]
- Incidence of BTX-A - Emergent Adverse event [ Time Frame: At baseline, 1, 3 and 6 months ]Safety of BTX-A, particularly for potential systemic adverse effects, will be assessed throughout the study. Adverse events will be declared in the case report form (CRF).
- Pain related to injections of BTX-A [ Time Frame: At baseline, 1, 3 and 6 months ]Pain related to injections will be rated as mild, moderate, or severe.
- Time course of the pain: [ Time Frame: At baseline, 1, 3 and 6 months ]measurement of the time course of the pain throughout the day with a diary (diary 1) in which the patient reports his/her pain every hour on a numeric scale (0-10) during 7 days.
- Thermography [ Time Frame: At baseline, 1, 3 and 6 months ]measurement (in °C), by a camera with a thermal sensitivity

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria
- Informed consent form signed
- Adult patients, age 18 -75 y.o.
- Medical coverage (excepted AME)
- Understanding of all medical information
- Subjects fulfilling diagnostic criteria for Peripheral painful traumatic trigeminal neuropathy (PPTTN)
- Pain in one or several branches of the trigeminal nerve
- History of surgical treatment (including endodontic treatments) in the painful area
- Pain in the area experienced in the 3 months following the treatment
- pain almost every day for at least 6 months
- VAS ≥ 30 /100 mm
- Primary painful area limited to one dental quadrant
- Presence of at least one positive (hyperalgesia, allodynia, numbness or swelling) and/or negative (anesthesia or hypoesthesia) sign of neurological dysfunction
- Pain cannot be attributed to another cause
Exclusion criteria
- Patients with impaired communication
- Pregnancy, breastfeeding or planning pregnancy within the period of the study
- Women of childbearing potential (WOCBP), adequate method of contraception within the period of the study
- Orofacial pain other than PPTTN unless clearly identifiable TMD (arthralgia, muscle pain or disc displacement)
- Contra-indications for BTX-A (for example diseases of the neuromuscular junction, known hypersensitivity to BTX-A etc.)
- Known coagulation disorders
- Major depression (score > XX HADS scale)
- Background of drug consumption or excessive alcohol consumption (3 units of alcohol a day)
- current legal dispute with a dental practitioner
- Former use of BTX for esthetic purpose
- Dysphagia
- Aspiration pneumonitis
- Troubles with bladder control
- Concomitant use of analgesics with dosage modification since less one month before inclusion in the study
- Topical applications of drugs and anesthetics which cannot be interrupted one week before visit sessions
- Treatment with aminoglycosides in the three months preceding the selection
- Participation to another interventional clinical study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555916
Contact: Yves BOUCHER, DDS,PhD | 01 42 16 14 56 | yves.boucher@univ-paris-diderot.fr |
France | |
Groupe Hospitalier Pitié-Salpêtrière | Recruiting |
Paris, France | |
Contact: Boucher Yves, DDS, PhD 01 42 16 14 56 yves.boucher@univ-paris-diderot.fr |
Principal Investigator: | Yves BOUCHER, DDS,PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT03555916 |
Other Study ID Numbers: |
P150901 2017-002353-11 ( EudraCT Number ) |
First Posted: | June 14, 2018 Key Record Dates |
Last Update Posted: | November 9, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
BOTOX®-Allergan PPTTN Pain measurements |
Trigeminal Nerve Diseases Trigeminal Nerve Injuries Facial Neuralgia Facial Nerve Diseases Mouth Diseases Stomatognathic Diseases Cranial Nerve Diseases Nervous System Diseases Cranial Nerve Injuries Craniocerebral Trauma Trauma, Nervous System |
Wounds and Injuries Botulinum Toxins, Type A abobotulinumtoxinA Neuromuscular Agents Peripheral Nervous System Agents Physiological Effects of Drugs Acetylcholine Release Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Cholinergic Agents Neurotransmitter Agents |