clonazepam and Bruxism, Nocturnal

clonazepam has been researched along with Bruxism, Nocturnal in 4 studies

Clonazepam: An anticonvulsant used for several types of seizures, including myotonic or atonic seizures, photosensitive epilepsy, and absence seizures, although tolerance may develop. It is seldom effective in generalized tonic-clonic or partial seizures. The mechanism of action appears to involve the enhancement of GAMMA-AMINOBUTYRIC ACID receptor responses.
clonazepam : 1,3-Dihydro-2H-1,4-benzodiazepin-2-one in which the hydrogens at positions 5 and 7 are substituted by 2-chlorophenyl and nitro groups, respectively. It is used in the treatment of all types of epilepsy and seizures, as well as myoclonus and associated abnormal movements, and panic disorders. However, its use can be limited by the development of tolerance and by sedation.

Research

Studies (4)

Authors

Clinical Trials (2)

Trial Overview

Trial Outcomes

Compliance -- Appliance Removal at Night

"Responses to the question, I frequently remove the splint during the night with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear." (NCT02340663)
Timeframe: 4 months

Compliance -- Use of Alternative Devices

"Responses to the question, I use an additional splint with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear." (NCT02340663)
Timeframe: 4 months

Fabrication Efficacy -- Retention Trials Week 1

Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth. (NCT02340663)
Timeframe: 1 week

Fabrication Efficacy -- Retention Trials, Month 4

Number of times splint was dislodged while performing eight different movements, with each movement being performed five times (maximum number therefore = 40). Dislodgement meant that, after performing the movement, the splint either fell off the teeth completely or that biting down on the splint resulted in its being reseated on the teeth. (NCT02340663)
Timeframe: 4 months

Fabrication Efficacy -- Tissue Adaptation, Facial Rim. Number of Participants With Poor Adaptation

Lip- and cheek-sides of splints were evaluated for contact with the premolar and molar teeth. Splints lacking contact (> 1 mm space between splint and teeth) were graded as 1 (poor adaptation); splints with < 1 mm space between splint and teeth, from molar to molar as 0 (good adaptation). Inter-proximal contacts Number of total participants with splints in each group with poor adaptation is reported. (NCT02340663)
Timeframe: Day of Delivery

Fabrication Efficacy -- Tissue Adaptation, Number of Subjects Whose Splints Had Excessive Material

Splint rims were evaluated for thickness. Splints requiring modification by the attending dentist to remove excess material were graded as 1 (poor adaptation); splints that did not require removal of excess material were graded as 0 (good adaptation). Number of participants in each group whose splint manifest poor adaptation is reported. (NCT02340663)
Timeframe: Day of Delivery

Fabrication Efficacy -- Tissue Adaptation, Palatal Rim. Number of Participants With Poor Adaptation

Palate-side of splints was evaluated for contact with the palate. Splints that were > 1 mm from contact with palate, from molar to molar were graded as 1 (poor adaptation); splints in continuous contact or lacking contact < 1mm with palate, from molar to molar were graded as 0 (good adaptation). Number of participants with splints in each group with poor adaptation is reported. (NCT02340663)
Timeframe: Day of delivery

Fabrication Efficacy -- Tissue Adaptation, Tightness. Number of Participants Reporting Excessive Tightness

Splints were evaluated for sensation of tightness on the teeth. SOVA splints that were said to be too tight by the participants and that subsequently required intervention by the attending dentist to fix were graded as 1 (poor adaptation); Michigan splints that were said to be too tight by the participants and that required the attending dentist to spend > 15 minutes of the delivery appointment to fix were graded as 1 (poor adaptation); all splints not meeting these criteria were scored as 0 (good adaptation). Total participants in each group with poorly adapted splints is reported. (NCT02340663)
Timeframe: Day of Delivery

Functional Efficacy -- Alteration of Bruxism Habit, Self Report of Reduced Bruxism

"Responses to the question, The splint helps my bruxism. with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear." (NCT02340663)
Timeframe: 4 months

Functional Efficacy -- Alteration of Bruxism Habit, Self-Report of Muscle Relaxation

"Responses to the question, The splint relaxes my jaw muscles. with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of 4 months of splint wear." (NCT02340663)
Timeframe: 4 months

Functional Efficacy -- Tooth Wear

Tooth wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the teeth in the lower jaw on the delivery data were combined with high-resolution, computer-scanned models of the same teeth and jaw after 4 months of splint wear. Sites where teeth showed cratering due to dentin exposure were targeted to make these measurements. Changes in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of dentin exposure areas (~ 1 millimeter in diameter). Group means were compared with t-tests. (NCT02340663)
Timeframe: 4 months

Number of Bruxing Events Per Hour Sleep Per Night.

Polysomnographic monitors were used to evaluate masticatory muscle activity during sleep. Activity of jaw closing muscles found in the cheeks (masseter muscles) occur in bursts, where a burst is taken as evidence for a jaw clench. The total number of bursts recorded during the night was tabulated and then divided by the total hours of sleep. Means presented are based on data gathered on night 122 (4 months of splint wear) and compared with ANOVA. (NCT02340663)
Timeframe: 4 months

Splint Material Loss / 4 Months.

Splint wear measured in millimeters. The number is negative to reflect the amount lost, e.g., -0.1 = a tenth of a millimeter lost. High-resolution, computer-scanned models of the splint on the delivery date were combined with high-resolution, computer-scanned models of the same splint after 4 months of wear. Sites where teeth contacted the splints were identified, and material loss in these areas was quantified using a computer program designed to quantify differences between two computer models. The measurement represents the difference between the two models, defined by a mean value sampled from a standard-sized area, which was set to be about the size of a tooth cusp (~ 3 millimeters in diameter). Group means were compared with t-tests. (NCT02340663)
Timeframe: 4 months

Total Number of Nights of Splint Wear for Four Months Per Subject.

Count of the total number of entire nights that subjects wore the splint provided to them in the study. (NCT02340663)
Timeframe: 4 months

User Satisfaction -- Self-Report of Splint Fit

"Responses to the question, The splint fits well with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out during the final appointment." (NCT02340663)
Timeframe: 4 months

Fabrication Efficacy -- Estimated Bite Forces During Stability Testing

Estimated bite forces in kilograms associated with performing each of the following tasks: moving the jaw in extreme positions with pressure against the splint (Border), clenching (Clench), grinding side to side (Grind Lateral), grinding front to back (Grind Protrusive), tapping hard on splint (Tap). Overall means for each treatment group (SOVA and Michigan splints) are also reported. (NCT02340663)
Timeframe: 4 months

Fabrication Efficacy -- Oral Health Modified Gingival Index

Gums or gingiva around each tooth is quantified for absence of inflammation (0), mild inflammation around part of the gingiva next to the tooth (1), mild inflammation involving all of the gingiva next to the tooth (2), moderate inflammation (3), or severe inflammation (4). Average scores are created for the cheek side of the upper teeth (Buccal Upper), palate side of upper teeth (Lingual Upper), cheek side of lower teeth (Buccal Lower) and tongue side of lower teeth (Lingual Lower). Mean and standard deviation scores for each of these regions and for week 1 and month 4 are shown as descriptive statistics; statistical results for the between-subject effects are reported. Overall means for each treatment group (SOVA and Michigan splints) are also reported. (NCT02340663)
Timeframe: 1 week and 4 months

Fabrication Efficacy -- Oral Health Plaque Index

The Rustogi et al. Modification of the Navy Plaque Index method of scoring plaque was used. This involves dividing the cheek-facing (Buccal) and the tongue/palate-facing (Lingual) surfaces of each tooth into 9 regions and scoring whether disclosed plaque is present (1) or absent (0) in each of these 9 regions. The total number of regions with plaque was then tabulated as the proportion of total regions for four mouth areas, viz., the cheek sides of the upper teeth (Buccal Upper), the cheek sides of the lower teeth (Buccal Lower), the palate sides of the upper teeth (Lingual Upper) and the tongue sides of the lower teeth (Lingual Lower). Overall means for each treatment group (SOVA and Michigan splints) are also reported. (NCT02340663)
Timeframe: 1 week and 4 months

Stability -- Number of Splints Dislodged by Clenching

Count of the number of participants whose individual splints were dislodged at least once when participants clenched their teeth against the splint five times. Numbers are sorted into those that moved < 1 mm, those that moved between 1 - 2 mm, those that moved between 2 - 3 mm and those that moved > 6 mm during the performance of five repeats of clenching. Categories from 3 mm to 6 mm are not included, because no splints fell into this range of values. (NCT02340663)
Timeframe: 4 months

Stability -- Number of Splints Dislodged by Grinding

Count of the number of participants whose individual splints were dislodged at least once when participants ground their teeth against the splint to the left (5 times), to the right (5 times, and front to back (5 times). Count is partitioned into those dislodged by < 1 mm, between 1 - 2 mm, between 2 - 3 mm, between 3 - 4 mm, and > 6 mm. Categories between 4 and 6 mm are not included, as no splints fell into this range. (NCT02340663)
Timeframe: 4 Months

Stability -- Number of Splints Dislodged by Tapping

Count of the number of participants whose individual splints were dislodged at least once when participants tapped their teeth on the splint 5 times. Counts are partitioned into the number dislodged < 1 mm, and those dislodged between 1 - 2 mm. (NCT02340663)
Timeframe: 4 months

Stability -- Number of Splints Dislodged During Border Movement Trials

Count of the number of participants whose individual splints were dislodged at least once when participants performed grinding-like movements of the teeth against the splint in extreme positions. These extreme movements and positions were performed 5 times. Counts are partitioned into those dislodged > 1 mm, those dislodged between 1 - 2 mm, those dislodged 2 - 3 mm, those dislodged 3 - 4 mm, those dislodged 4 - 5 mm, those dislodged 5 - 6 mm and those dislodged > 6 mm. (NCT02340663)
Timeframe: 4 months

Stability -- Number of Splints Dislodged During Maximum Openings

Count of the number of participants whose individual splints were dislodged at least once when participants opened as wide as possible and then closed. The task was repeated five times. Counts are partitioned into the number dislodged < 1 mm, number dislodged between 1 - 2 mm, number dislodged between 2 - 3 mm, number dislodged between 3 - 4 mm and number dislodged between 4 - 5 mm. (NCT02340663)
Timeframe: 4 Months

Stability -- Splint Movement During Jaw Movement Tasks

Movement of each subject's splint on the teeth, due to rocking or dislodgement, measured in millimeters during five repetitions of the following five tasks: clenching, grinding, moving jaw to extreme positions on the splint, tapping, opening maximally. For control, movements of the splint while the jaw was in a rest position (teeth apart, jaw relaxed) were also measured. The maximum movement during the five repetitions of each task was calculated for each subject and used in statistical analyses. (NCT02340663)
Timeframe: 4 months

User Satisfaction -- Ease of Instructions

"Responses to the question, The instructions were easy to follow with a 5-point Likert scale, anchored on the left with Strongly Disagree (receiving a score of 0) and on the right with Strongly Agree (receiving a score of 4). Question was filled out at the end of the appointment during which time the splints were made by participants." (NCT02340663)
Timeframe: On day of delivery

Trials

2 trials available for clonazepam and Bruxism, Nocturnal

Other Studies

2 other studies available for clonazepam and Bruxism, Nocturnal