Clinical trial NCT05125731: Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment
Official title: Evaluation of the Effect of Parental Absence on Child's Dental Anxiety and Behaviors During Dental Treatment: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Anxiety
Children, Only
Dental Caries
Keywords: Behaviour management
Dental fear
Parental absence
Lead sponsor: Ankara Yildirim Beyazıt University
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The aim of this clinical study is:

* to determine the presence or absence of the parent during the treatment in order to ensure the cooperation of the child during the dental treatment
* to investigate the relationship between the parent's dental fear and the child's dental fear

  72 healthy children aged 4-7 will be recruited from Ankara Yıldırım Beyazıt University Faculty of Dentistry, Department of Pediatric Dentistry outpatient clinic.

Participants who met the inclusion criteria and agreed to participate will be randomly allocated to Group 1 (Parental absence), Group 2 (Parent behind a barrier) or Group 3 (Parental presence).

A simple randomization method will be used with opaque sealed envelopes containing "Group 1", "Group 2" or "Group 3" prepared separately for 4 different ages (4, 5, 6 and 7) in the study. Group allocation will be performed by an independent researcher, not involved in the study.

"Venham Picture Test" and "The Dental Subscale of the Children's Fear Survey Schedule" questionnaire will be applied to the children before and after the dental treatments.

The parent's dental anxiety will be measured with "The Corah Dental Anxiety Scale" and parent's attitude will be measured with "Parental Attitude Scale".

During the dental treatments the heart rate and the blood oxygen saturation of each participant will be recorded at 30-second intervals. The mean number of these measurements will be calculated for each of the following processes.

1. Sitting in the dental chair at the beginning of the treatment
2. Administration of topical anesthesia
3. Administration of local anesthesia
4. Caries removal with high-speed rotary instrument
5. Caries removal with low-speed rotary instrument
6. Application of dental matrix
7. Placement of dental filling material
8. Restoration finishing and polishing
9. Sitting in the dental chair at the end of the treatment

Video recordings taken during dental treatment will be watched later by a dentist who is blind to the treatment groups and the child's cooperation during treatment will be recorded using the Frankl behavioral scale.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: 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.
timeFrame: 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
measure: Mean change from baseline in children's dental anxiety scores on Venham Picture Test at the end of the dental treatment.
timeFrame: 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
measure: Heart rate measurement to assess dental anxiety
timeFrame: during dental treatment
measure: Blood oxygen saturation measurement to assess dental anxiety
timeFrame: during dental treatment
measure: Frankl behavioral scale to measure compliance to dental treatment
timeFrame: during dental treatment
Secondary outcomes:
measure: The Corah Dental Anxiety Scale to measure the parent's dental anxiety
timeFrame: At the first visit- immediately after being assigned to one of the three study arms
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Yıldırım Beyazıt University Faculty of Dentistry
Study officials:
affiliation: Ankara Yıldırım Beyazit University Faculty of Dentistry
name: Ayse I. Orhan, Assoc. Prof.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Frankl SN, Shiere FR, Fogels HR. Should the parent remain with the child in the dental operatory? J Dent Child 1962; 29: 150-163.