NCT07711431

Brief Summary

This study investigates whether there is an association between periodontal disease (gum disease) and chronic neck pain and related functional disability. Participants aged 30-55 years will be grouped based on their periodontal health status (healthy, gingivitis, or periodontitis). Neck pain intensity will be assessed using the Visual Analog Scale (VAS), and functional disability will be measured using the Neck Disability Index (NDI). The study aims to determine whether periodontal disease severity is linked to the severity of neck pain and disability, which may help clarify a potential connection between oral health and musculoskeletal health.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
123

participants targeted

Target at P50-P75 for all trials

Timeline
1mo left

Started Jul 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
Jul 2026Sep 2026

Study Start

First participant enrolled

July 11, 2026

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 17, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2026

Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

July 14, 2026

Last Update Submit

July 14, 2026

Conditions

Keywords

Periodontal DiseaseGingivitisPeriodontitisNeck PainNeck DisabilityOral HealthMusculoskeletal Pain

Outcome Measures

Primary Outcomes (2)

  • Neck Pain Intensity (Visual Analog Scale, VAS)

    Neck pain intensity will be assessed using the Visual Analog Scale (VAS), a 10-cm horizontal line ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will mark the point that best represents their current level of neck pain. Scores will be compared across periodontal health groups (healthy, gingivitis, periodontitis).

    Assessed at the time of study enrollment (baseline, single time point)

  • Neck-Related Functional Disability (Neck Disability Index, NDI)

    Functional disability related to neck pain will be assessed using the Neck Disability Index (NDI), a validated 10-item self-report questionnaire evaluating the impact of neck pain on daily activities. Scores will be compared across periodontal health groups (healthy, gingivitis, periodontitis).

    Assessed at the time of study enrollment (baseline, single time point)

Study Arms (3)

Healthy

Participants with a clinically healthy periodontium, showing no clinical signs of gingival inflammation, attachment loss, or bone loss on periodontal examination.

Gingivitis

Participants diagnosed with gingivitis based on clinical periodontal examination, showing signs of gingival inflammation without attachment or bone loss.

Periodontitis

Participants diagnosed with periodontitis (Stage I, II, III, or IV) according to the 2017 World Workshop classification of periodontal and peri-implant diseases and conditions.

Eligibility Criteria

Age30 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults aged 30-55 years attending the Department of Periodontology, Faculty of Dentistry, Niğde Ömer Halisdemir University, who will be classified into three groups based on periodontal health status: clinically healthy periodontium, gingivitis, or periodontitis (Stage I-IV).

You may qualify if:

  • Aged between 30 and 55 years
  • Willing to participate and provide written informed consent
  • Able to undergo periodontal examination and complete self-report questionnaires

You may not qualify if:

  • Neck pain attributable to a specific identifiable cause (e.g., trauma, cervical disc herniation, spinal deformity, tumor, fracture)
  • Systemic inflammatory or autoimmune disease
  • Neurological disease affecting the cervical region
  • Pregnancy
  • Regular use of analgesic or anti-inflammatory medication
  • Fewer than 20 remaining natural teeth
  • History of periodontal treatment within the past 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Niğde Ömer Halisdemir University, Faculty of Dentistry

Niğde, Niğde Province, 51240, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontal DiseasesGingivitisPeriodontitisNeck PainMusculoskeletal Pain

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Central Study Contacts

Şafak Necati Dönertaş, DDS

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 14, 2026

First Posted

July 17, 2026

Study Start

July 11, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

September 15, 2026

Last Updated

July 17, 2026

Record last verified: 2026-07

Locations