Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment

NCT05125731 | Completed

• 1 other identifier: E2-21-738
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The basis of pediatric dentistry is to provide cooperation in children with various behavioral management techniques. The presence or absence of the parent during dental treatments can be used to ensure the child's compliance with the treatment. The aim of this study is to investigate the effect of the presence or absence of the parent on the child's dental anxiety and child's behavior during dental treatment. The secondary aim is to examine the relationship between the child's dental fear and the parent's dental fear. Healthy children between the ages of 4-7, who have no dental experience and need restorative treatment will be included in the study. Participants will be randomly assigned to one of three study groups (Group 1: Parental absence, Group 2: Parent behind a barrier and Group 3: Parental presence). Psychometric and projective tests will be applied to assess child's and parent's dental anxiety at the beginning of the study. At the second appointment scheduled for the operative treatment of decayed primary molar tooth, first the child will be administered topical and local anesthesia, a rubber dam will be placed on the decayed tooth, the caries will be removed with high and low speed rotary instruments and the cavity will be restored with a compomer filling. Children's heart rates and blood oxygen saturation will be measured by a pulse oximeter during treatment in order to evaluate dental anxiety. Children will be videotaped during treatment so that their behaviour can be evaluated later by another researcher. After treatment, psychometric and projective tests used to measure the child's dental anxiety will be re-administered.

Conditions

Dental Anxiety; Children, Only; Dental Caries

Keywords

Behaviour management; Dental fear; Parental absence

Outcome Measures

Primary Outcomes (5)

• Mean change from baseline in children's dental anxiety scores on Children's Fear Survey Schedule-Dental Subscale (CFSS-DS) at the end of the dental treatment.

  The CFSS-DS is a 15-item questionnaire on various aspects of dental treatment. Each item can be given five different scores ranging from "not afraid at all (1)" to "very much afraid (5)." The CFSS-DS has a total score range of 15 to 75 and a score of 38 or more has been associated with clinical dental fear.

  1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment

• Mean change from baseline in children's dental anxiety scores on Venham Picture Test at the end of the dental treatment.

  The Venham picture test is comprised of 8 pairs of images, where each pair represents one anxious figure and one non-anxious figure. The children are asked to select the ones that reflect their emotional state best. The anxious figure gets 1 point, and the non-anxious figure gets 0 points. The final score ranges from 0 (least anxious) to 8 (most anxious).

  1. At the first visit- immediately after being assigned to one of the three study arms; 2. At the second visit- within 30 min after dental treatment

• Heart rate measurement to assess dental anxiety

  Measurement will be made with a pulse oximeter

  during dental treatment

• Blood oxygen saturation measurement to assess dental anxiety

  Measurement will be made with a pulse oximeter

  during dental treatment

• Frankl behavioral scale to measure compliance to dental treatment

  Frankl behavior scale classifies child behavior into four categories (1-definitely negative 2- negative, 3- positive and 4- definitely positive) according to the child's attitude during dental treatment. The video recording taken during the treatment will be evaluated by another researcher. In the "parental presence group" where the parent accompanies the child, the parent will be seated outside the camera's field of view.

  during dental treatment

Secondary Outcomes (1)

• The Corah Dental Anxiety Scale to measure the parent's dental anxiety

  At the first visit- immediately after being assigned to one of the three study arms

Study Arms (3)

Parental absence

EXPERIMENTAL

The parent will not be present in the dental clinic during the treatment. Parents will be instructed to wait in a waiting room outside the clinic, out of sight of the child.

Behavioral: Parental absence

Parental visual support

ACTIVE COMPARATOR

The parent will watch and wait behind a transparent barrier without disrupting the interaction between the dentist and the child. This type of separation differs from the total absence of the parent because the parent is within the child's sight.

Behavioral: Parental visual support

Parental presence

ACTIVE COMPARATOR

One of the parents will accompany the child during the dental treatment. The parent is allowed to sit next to the child without disturbing the interaction between the dentist and the child.

Behavioral: Parental presence

Interventions

Parental absence BEHAVIORAL

Parent does not accompany the child during dental treatment

Parental absence

Parental visual support BEHAVIORAL

The parent does not accompany the child during the dental treatment but watches behind the glass and is seen by the child.

Parental visual support

Parental presence BEHAVIORAL

Parent accompanies the child during dental treatment

Parental presence

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• No previous dental treatment experience
• No need for urgent dental treatment
• Presence of at least one interproximal carious lesion in a primary molar tooth with a lesion depth does not exceeding 1/2 of the inner dentin radiographically and without irreversible pulp pathology

You may not qualify if:

• Any systemic disease, physical or mental disorder
• Uncooperative child who absolutely refuses dental treatment

Sponsors & Collaborators

• Ankara Yildirim Beyazıt University: lead

Study Sites (1)

Ankara Yıldırım Beyazıt University Faculty of Dentistry

Ankara, Turkey (Türkiye)

Location

Related Publications (8)

• Gustafsson A, Broberg A, Bodin L, Berggren U, Arnrup K. Dental behaviour management problems: the role of child personal characteristics. Int J Paediatr Dent. 2010 Jul;20(4):242-53. doi: 10.1111/j.1365-263X.2010.01046.x.

  PMID: 20536585 BACKGROUND

• Kantaputra PN, Chiewcharnvalijkit K, Wairatpanich K, Malikaew P, Aramrattana A. Children's attitudes toward behavior management techniques used by dentists. J Dent Child (Chic). 2007 Jan-Apr;74(1):4-9.

  PMID: 18430348 BACKGROUND

• Versloot J, Veerkamp J, Hoogstraten J. Dental anxiety and psychological functioning in children: its relationship with behaviour during treatment. Eur Arch Paediatr Dent. 2008 Feb;9 Suppl 1:36-40. doi: 10.1007/BF03262654.

  PMID: 18328247 BACKGROUND

• Klingberg G, Berggren U, Noren JG. Dental fear in an urban Swedish child population: prevalence and concomitant factors. Community Dent Health. 1994 Dec;11(4):208-14.

  PMID: 7850639 BACKGROUND

• Corah NL, Gale EN, Illig SJ. Assessment of a dental anxiety scale. J Am Dent Assoc. 1978 Nov;97(5):816-9. doi: 10.14219/jada.archive.1978.0394.

  PMID: 31377 BACKGROUND

• Venham LL, Gaulin-Kremer E. A self-report measure of situational anxiety for young children. Pediatr Dent. 1979 Jun;1(2):91-6. No abstract available.

  PMID: 399677 BACKGROUND

• Cuthbert MI, Melamed BG. A screening device: children at risk for dental fears and management problems. ASDC J Dent Child. 1982 Nov-Dec;49(6):432-6. No abstract available.

  PMID: 6960031 BACKGROUND

• Frankl SN, Shiere FR, Fogels HR. Should the parent remain with the child in the dental operatory? J Dent Child 1962; 29: 150-163.

  BACKGROUND

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ayse I. Orhan, Assoc. Prof.

  Ankara Yıldırım Beyazit University Faculty of Dentistry

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Researcher evaluating child's behavior by watching video recordings taken during dental treatment and biostatistician will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 26, 2021
• First Posted: November 18, 2021
• Study Start: October 1, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 6, 2025

Record last verified: 2025-10

Locations

TU (1)