NCT07306117

Brief Summary

Studies have shown that Swedish adolescents have poor oral hygiene and with high prevalence of gingivitis. Therefore, more effective preventive programs in dental care are needed. The project aims to examine whether a health application and follow-up person-centered digital meetings can serve as support in person-centered and theory-based behavioral interventions to promote and maintain positive oral health habits.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress17%
Jan 2026Dec 2027

First Submitted

Initial submission to the registry

December 4, 2025

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

December 29, 2025

Status Verified

November 1, 2025

Enrollment Period

2 years

First QC Date

December 4, 2025

Last Update Submit

December 18, 2025

Conditions

Keywords

Qualitative studyGingivitisPlaquepreventionperiodontal diseasebehavioral change interventionperson-centered carebehavioral medicineadolescentsoral healthoral hygienequalitative interviews

Outcome Measures

Primary Outcomes (1)

  • Qualitative interviews

    This pilot study has mainly a qualitative approach where the adolescents and the dental hygienists who provide the treatment will be interviewed regarding experiences and views on the health application for self-monitoring and supportive person-centered digital meetings.

    12 months after baseline.

Study Arms (1)

Person-centered, theory-based, intervention

EXPERIMENTAL

This treatment is the most recommended when behavioral change is needed to promote adequate oral hygiene - based on the Swedish National Guidelines for Dental Care (National Board of Health and Welfare, 2022). The aim is to, with a qualitative approach, explore views on the health application for self-monitoring and supportive person-centered digital maintenance meetings to promote new/positive oral hygiene habits.

Behavioral: Person-centered, theory-based, intervention

Interventions

The person-centered intervention is based on theory of health behavior and includes behavior change techniques (personal goal setting for oral hygiene and oral health, planning, and monitoring of behavior). The dental hygienists use a collaborative communication method inspired by motivational interviewing. This intervention is the most recommended treatment for behavior change in cases of unhealthy lifestyle habits according to the National Guidelines for Dental Care (The National Board of Health and Welfare, 2022). The initial intervention phase includes three visits: Visit 1 (Baseline) - face-to-face (approx. 60 min) Visit 2 (2-3 weeks after baseline) - face-to-face (approx. 40 min) Visit 3 (10-12 weeks after baseline) - digital (approx. 30 min) After 6 months, a follow-up is conducted (Visit 4 - face-to-face, approx. 40 min). Between 6 and 12 months (maintenance phase), one digital meeting is offered to support maintenance of new/positive oral hygiene habits.

Person-centered, theory-based, intervention

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Adolescents (16-17 years)
  • Gingivitis and/or plaque on ≥50% of tooth surfaces at dental examination.

You may not qualify if:

  • Adolescents judged as not capable to understand the study information in order to make a considered choice about participation (The Swedish Ethical Review Act; SFS 2003:460, § 18).
  • Adolescents with obvious difficulties with the Swedish language.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folktandvården Västra Götaland

Gothenburg, 405 44, Sweden

Location

Related Publications (17)

  • Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. doi: 10.1016/j.nedt.2003.10.001.

    PMID: 14769454BACKGROUND
  • National Board of Health and Welfare (2022). Nationella riktlinjer för tandvård - stöd för styrning och ledning 2022 (in Swedish). Retrieved from https://www.socialstyrelsen.se/globalassets/sharepoint-dokument/artikelkatalog/nationella-riktlinjer/2022-9-8114.pdf in September 2025. Information in English about the guidelines: https://www.socialstyrelsen.se/en/clinical-practise-guidelines-and-regulations/regulations-and-guidelines/national-guidelines/

    BACKGROUND
  • Ostberg AL, Ericsson JS, Wennstrom JL, Abrahamsson KH. Socio-economic and lifestyle factors in relation to priority of dental care in a Swedish adolescent population. Swed Dent J. 2010;34(2):87-94.

    PMID: 20701217BACKGROUND
  • Werner H, Hakeberg M, Dahlstrom L, Eriksson M, Sjogren P, Strandell A, Svanberg T, Svensson L, Wide Boman U. Psychological Interventions for Poor Oral Health: A Systematic Review. J Dent Res. 2016 May;95(5):506-14. doi: 10.1177/0022034516628506. Epub 2016 Jan 29.

    PMID: 26826109BACKGROUND
  • Wahlin A, Papias A, Jansson H, Norderyd O. Secular trends over 40 years of periodontal health and disease in individuals aged 20-80 years in Jonkoping, Sweden: Repeated cross-sectional studies. J Clin Periodontol. 2018 Sep;45(9):1016-1024. doi: 10.1111/jcpe.12978. Epub 2018 Jul 27.

    PMID: 29971805BACKGROUND
  • Newton JT, Asimakopoulou K. Managing oral hygiene as a risk factor for periodontal disease: a systematic review of psychological approaches to behaviour change for improved plaque control in periodontal management. J Clin Periodontol. 2015 Apr;42 Suppl 16:S36-46. doi: 10.1111/jcpe.12356.

    PMID: 25639708BACKGROUND
  • Ericsson JS, Wennstrom JL, Lindgren B, Petzold M, Ostberg AL, Abrahamsson KH. Health investment behaviours and oral/gingival health condition, a cross-sectional study among Swedish 19-year olds. Acta Odontol Scand. 2016;74(4):265-71. doi: 10.3109/00016357.2015.1112424. Epub 2015 Nov 24.

    PMID: 26599291BACKGROUND
  • Ericsson JS, Ostberg AL, Wennstrom JL, Abrahamsson KH. Oral health-related perceptions, attitudes, and behavior in relation to oral hygiene conditions in an adolescent population. Eur J Oral Sci. 2012 Aug;120(4):335-41. doi: 10.1111/j.1600-0722.2012.00970.x. Epub 2012 Jun 25.

    PMID: 22813224BACKGROUND
  • Ericsson JS, Abrahamsson KH, Ostberg AL, Hellstrom MK, Jonsson K, Wennstrom JL. Periodontal health status in Swedish adolescents: an epidemiological, cross-sectional study. Swed Dent J. 2009;33(3):131-9.

    PMID: 19994563BACKGROUND
  • Dimenäs SL. Behavioral Intervention for Improved Oral Hygiene in Adolescents - A Person-Centered and Theory-Based Approach. 2024. PhD-thesis, University of Gothenburg, Sweden.

    BACKGROUND
  • Dimenas SL, Andersson JS, Jonsson B, Lundgren J, Petzold M, Ostberg AL, Abrahamsson KH. Adolescents' self-reported experiences following a person-centred, theory-based educational intervention versus conventional education for improved oral hygiene: Analysis of secondary outcomes of a randomized field study. J Clin Periodontol. 2024 Jan;51(1):63-73. doi: 10.1111/jcpe.13883. Epub 2023 Oct 11.

    PMID: 37822115BACKGROUND
  • Dimenas SL, Jonsson B, Lundin M, Lundgren J, Abrahamsson KH. Changing from disease-centred to person-centred - Swedish dental hygienists' views on a theory-based behavioural intervention for improved oral hygiene among adolescents. Int J Dent Hyg. 2024 Nov;22(4):971-981. doi: 10.1111/idh.12811. Epub 2024 Apr 24.

    PMID: 38659277BACKGROUND
  • Dimenas SL, Ostberg AL, Lundin M, Lundgren J, Abrahamsson KH. Adolescents' experiences of a theory-based behavioural intervention for improved oral hygiene: A qualitative interview study. Int J Dent Hyg. 2022 Nov;20(4):609-619. doi: 10.1111/idh.12606. Epub 2022 Aug 15.

    PMID: 35925040BACKGROUND
  • Dimenas SL, Jonsson B, Andersson JS, Lundgren J, Petzold M, Abrahamsson I, Abrahamsson KH. A person-centred, theory-based, behavioural intervention programme for improved oral hygiene in adolescents: A randomized clinical field study. J Clin Periodontol. 2022 Apr;49(4):378-387. doi: 10.1111/jcpe.13601. Epub 2022 Feb 23.

    PMID: 35132653BACKGROUND
  • Dimenäs SL. Smartphone-applikationer vid beteendeförändring: En litteraturstudie med fokus på interventioner i syfte att påverka unga individers hälsobeteende. Examensarbete för magister i Oral Hälsa, 15 hp. Göteborgs universitet, 2017

    BACKGROUND
  • Carra MC, Detzen L, Kitzmann J, Woelber JP, Ramseier CA, Bouchard P. Promoting behavioural changes to improve oral hygiene in patients with periodontal diseases: A systematic review. J Clin Periodontol. 2020 Jul;47 Suppl 22:72-89. doi: 10.1111/jcpe.13234.

    PMID: 31912530BACKGROUND
  • Abrahamsson KH, Koch G, Norderyd O, Romao C, Wennstrom JL. Periodontal conditions in a Swedish city population of adolescents: a cross-sectional study. Swed Dent J. 2006;30(1):25-34.

    PMID: 16708853BACKGROUND

MeSH Terms

Conditions

GingivitisPlaque, AmyloidPeriodontal Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesMouth DiseasesStomatognathic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Sandra L. Dimenäs, Odont. Dr

    Departement of Periodontology, Institute of Odontology, University of Gothenburg

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sandra L. Dimenäs, Odont. Dr.

CONTACT

Kajsa H. Abrahamsson, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Adolescents will be treated in accordance with the person-centered and theory-based intervention (based on social cognitive theory and including the behavioral change techniques goal setting, planing and self-monitoring) that was tested/evaluated in the previous treatment study, but where the written diary for self-monitoring of oral hygiene behavior is replaced by a mobile health application. The application is intended to be used for self-monitoring during the active/initial phase of the behavioral intervention, which includes two physical and one digital visit over 12 weeks, followed by a follow-up/evaluation visit at six months. In addition, after completion of the initial intervention phase, the adolescents will be offered a person-centered digital maintenance meeting as support to promote/maintain positive oral health/oral hygiene habits. The maintenance phase covers the period from six to twelve months when the treatment in the pilot study ends.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 29, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

December 29, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations