Evaluation of the Effects Using the Combination of Sedative Agents on Dental Anxiety in Pediatric Patients

NCT04623970 | Completed

• 1 other identifier: 82/2
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study were firstly, to evaluate the changes in the anxiety level after deep sedation with various intravenous sedative agents using salivary cortisol level in pediatric dental patients and secondly, to compare clinical effectiveness of this sedative agents, perioperative complications, recovery time and adverse effects.

Conditions

Anxiety Postoperative

Keywords

Dental anxiety; Deep Sedation; Ketofol; Propofol; Salivary Cortisol

Outcome Measures

Primary Outcomes (5)

• Dental anxiety (subjective)

  Units on a Scale (Patient's dental anxiety level was evaluated with Facial Image Scale after treatment. Patients signed from 1 to 5 score for dental anxiety.The data were collected and statistically analysed using by the numerical data. In this study, "1" and "2" scores are considered as better outcome. Patients who signed these scores described as no anxiety. The worst outcome is considered as the patients signed "4-5". Each scale range for each time interval evaluated as count of patient and presented as percentage.)

  through study completion, an average of 12 months

• Dental anxiety (objective)

  Units on Saliva cortisol levels (Dental anxiety was evaluated with Enzyme-linked immunosorbent assay after treatment.The patients were measured from 0 to 200 nmol/L for dental anxiety after the treatment.The data were collected and statistically analysed using by the numerical data. In this study, " 0-28 nmol/L'' are considered as better outcome. Patients who were have these scores described no dental anxiety for deep sedation. The worst outcome is considered as the anxious patients have "\>28 nmol/L ". Each value range for each time interval evaluated as count of patient and presented as percentage.)

  through study completion, an average of 12 months

• Depth of sedation

  Units on a Scale (Depth of sedation was evaluated with Ramsay Sedation Scale during the sedation. Observer signed from 0 to 5 score for depth of sedation during the treatment.The data were collected and statistically analysed using by the numerical data. In this study, "4-5" scores are considered as better outcome. Patients who were signed these scores described as sedated patients for dental treatment. The worst outcome is considered as the patients signed "0-3". Each scale range for each time interval evaluated as count of patient and presented as percentage.)

  through study completion, an average of 12 months

• Postperative complications

  Units on a Scale ( Postoperative complications were evaluated with a form which was included absence or presence of agitation, hypersalivation, nausea-vomiting and double vision. Observer signed absence or presence for each complications after the treatment.The data were collected and statistically analysed using by the numerical data)

  through study completion, an average of 12 months

• Perioperative complications

  Units on a Scale (Perioperative complications were evaluated with a form which was included absence or presence of local injection pain, cough, saturation drop and spontaneous movement. Observer signed absence or presence for each perioperative complications during the deep sedation.The data were collected and statistically analysed using by the numerical data)

  through study completion, an average of 12 months

Secondary Outcomes (3)

• Heart Rate

  through study completion, an average of 12 months

• Systolic and diastolic arterial pressure

  through study completion, an average of 12 months

• Oxygen saturation

  through study completion, an average of 12 months

Study Arms (3)

Propofol sedation group

EXPERIMENTAL

Patients in this experimental group received propofol sedation agent.

Procedure: Dental Treatment

Ketofol 1:3 sedation group

EXPERIMENTAL

Patients in this experimental group received ketofol sedation agent as a 1:3 mixture.

Procedure: Dental Treatment

Ketofol 1:4 sedation group

EXPERIMENTAL

Patients in this experimental group received ketofol sedation agent as a 1:4 mixture.

Procedure: Dental Treatment

Interventions

Dental Treatment PROCEDURE

Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation

Ketofol 1:3 sedation group; Ketofol 1:4 sedation group; Propofol sedation group

Eligibility Criteria

• Age: 3 Years - 7 Years
• Gender Eligibility Details: 35 Male and 34 Female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Pediatric patients age between 3-7 years old
• Having no systemic condition and ASA 1 healty status
• Having high dental anxiety
• Having no dental treatment under the sedation or general anesthesia before
• Having no dental treatment before

You may not qualify if:

• Having obstructed nasal passages, raised intracranial or intraocular pressure, allergy
• Using any drug which effected saliva construction
• Having enough saliva for saliva cortisol evaluation

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University

Adana, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Dental Care

Intervention Hierarchy (Ancestors)

Dentistry; Dental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• volkan Ciftci

  Cukurova University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 10, 2020
• Study Start: November 28, 2018
• Primary Completion: January 23, 2020
• Study Completion: October 5, 2020
• Last Updated: November 13, 2020

Record last verified: 2020-11

Locations

TU (1)