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

November 10, 2020 updated by: volkan Ciftci, Cukurova University

Çocuk Hastalarda Değişik Konsantrasyonlarda Kullanılan Sedasyon Ajanlarının Anksiyete Üzerine Etkilerinin Değerlendirilmesi

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This clinical study was included 69 healthy pediatric patients aged 3 to 7 years with high anxiety. The patients were divided into 3 groups according to the sedative agents: Group 1 (n=23) was received Propofol, Group 2 (n=23) was receieved Ketofol 1:3, and Group 3 (n=23) was received Ketofol 1:4. The anxiety levels were assessed using Facial Image Scale (FIS) anxiety scale and changes in salivary cortisol levels were assessed using ELISA before and after the drug administration. Perioperative vital signs, depth of sedation were recorded at intervals of 5 minutes. Preoperative and postoperative complications, operation and recovery time were recorded in the follow-up form.

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Adana, Turkey
        • Cukurova University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Propofol sedation group
Patients in this experimental group received propofol sedation agent.
Procedure: Dental Treatment
Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation
EXPERIMENTAL: Ketofol 1:3 sedation group
Patients in this experimental group received ketofol sedation agent as a 1:3 mixture.
Procedure: Dental Treatment
Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation
EXPERIMENTAL: Ketofol 1:4 sedation group
Patients in this experimental group received ketofol sedation agent as a 1:4 mixture.
Procedure: Dental Treatment
Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental anxiety (subjective)
Time Frame: through study completion, an average of 12 months
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)
Time Frame: through study completion, an average of 12 months
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
Time Frame: through study completion, an average of 12 months
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
Time Frame: through study completion, an average of 12 months
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
Time Frame: through study completion, an average of 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart Rate
Time Frame: through study completion, an average of 12 months
Differents Units of measure (Heart rate beats in bpm was measured per five minutes during the operation)
through study completion, an average of 12 months
Systolic and diastolic arterial pressure
Time Frame: through study completion, an average of 12 months
Differents Units of measure (Systolic and diastolic arterial pressures in mmHg were measured per five minutes during the operation)
through study completion, an average of 12 months
Oxygen saturation
Time Frame: through study completion, an average of 12 months
Differents Units of measure (Oxygen saturation in mmHg was measured per five minutes during the operation)
through study completion, an average of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Investigators

  • Study Director: volkan Ciftci, Cukurova University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 28, 2018

Primary Completion (ACTUAL)

January 23, 2020

Study Completion (ACTUAL)

October 5, 2020

Study Registration Dates

First Submitted

November 2, 2020

First Submitted That Met QC Criteria

November 9, 2020

First Posted (ACTUAL)

November 10, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 10, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 82/2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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