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

NCT ID: NCT04623970

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-28

Study Completion Date

2020-10-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Anxiety Postoperative

Keywords

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Dental anxiety Deep Sedation Ketofol Propofol Salivary Cortisol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Propofol sedation group

Patients in this experimental group received propofol sedation agent.

Group Type EXPERIMENTAL

Dental Treatment

Intervention Type 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

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

Group Type EXPERIMENTAL

Dental Treatment

Intervention Type PROCEDURE

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

Ketofol 1:4 sedation group

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

Group Type EXPERIMENTAL

Dental Treatment

Intervention Type PROCEDURE

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

Interventions

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Dental Treatment

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cukurova University

OTHER

Sponsor Role lead

Responsible Party

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volkan Ciftci

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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volkan Ciftci

Role: STUDY_DIRECTOR

Cukurova University

Locations

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Cukurova University

Adana, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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82/2

Identifier Type: -

Identifier Source: org_study_id