NCT07772115

Brief Summary

Stage III and Stage IV periodontitis are associated with loss of periodontal support, tooth mobility, and impaired oral function, which may affect occlusal force distribution and chewing performance. Although non-surgical periodontal therapy effectively improves periodontal health, its effect on functional occlusal parameters and mandibular movements has not been comprehensively evaluated using digital technologies. This prospective interventional study will investigate changes in occlusal force distribution and chewing cycle characteristics in patients with Stage III or Stage IV periodontitis before and after non-surgical periodontal therapy. Participants will receive standardized periodontal treatment and will be assessed at baseline, 8-12 weeks after completion of active therapy, and 3 months following re-evaluation. The T-Scan digital occlusal analysis system will be used to record occlusal force distribution, occlusion time, disocclusion time, and force balance. The Modjaw jaw-tracking system will be used to look at chewing cycle characteristics and mandibular movements. The study aims to determine whether periodontal therapy leads to measurable improvements in oral function and to provide objective functional outcome measures that may support periodontal and prosthodontic treatment planning.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
16mo left

Started Oct 2026

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

First Submitted

Initial submission to the registry

June 26, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 19, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

October 6, 2026

Expected
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2028

7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

August 19, 2026

Status Verified

August 1, 2026

Enrollment Period

1.3 years

First QC Date

June 26, 2026

Last Update Submit

August 17, 2026

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

  • Change in Right-Left Occlusal Force Balance

    Change in right-left occlusal force balance measured using the T-Scan digital occlusal analysis system.

    Baseline, 8-12 weeks after completion of non-surgical periodontal therapy, and 3 months after re-evaluation.

Secondary Outcomes (1)

  • Change in Chewing Cycle Characteristics

    Baseline, 8-12 weeks after therapy, and 3 months after re-evaluation.

Study Arms (1)

Non-Surgical Periodontal Therapy

EXPERIMENTAL
Procedure: Non-Surgical Periodontal Therapy

Interventions

Non-Surgical Periodontal TherapyPROCEDURE

Standardized non-surgical periodontal therapy consisting of oral hygiene instruction, supragingival debridement, and full-mouth subgingival instrumentation using ultrasonic scalers and hand instruments according to the European Federation of Periodontology (EFP) S3-level clinical practice guideline for Stage III and Stage IV periodontitis.

Non-Surgical Periodontal Therapy

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18-70 years.
  • Diagnosis of Stage III or Stage IV periodontitis (Grade A, B, or C) according to the 2018 World Workshop Classification.
  • Presence of at least 20 natural teeth, including posterior occlusal support.
  • No periodontal treatment within the preceding 12 months.
  • Willing and able to attend all scheduled follow-up appointments

You may not qualify if:

  • Systemic conditions known to impair periodontal healing, including:
  • Uncontrolled diabetes mellitus (HbA1c \>7%)
  • Immunosuppressive therapy
  • Bisphosphonate therapy
  • Removable prostheses replacing multiple posterior teeth.
  • Pregnancy or breastfeeding.
  • Current occlusal splint wearers.
  • Planned dental treatment other than periodontal therapy during the study period.
  • Heavy smokers (\>20 cigarettes/day).
  • Stage I or Stage II periodontitis, gingivitis, or a healthy periodontium.
  • Severe manual dexterity impairment preventing adequate oral hygiene.
  • Currently undergoing periodontal treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • Pereira LJ, Gazolla CM, Magalhaes IB, Dominguete MH, Vilela GR, Castelo PM, Marques LS, Van Der Bilt A. Influence of periodontal treatment on objective measurement of masticatory performance. J Oral Sci. 2012;54(2):151-7. doi: 10.2334/josnusd.54.151.

    PMID: 22790407RESULT

  • Palinkas M, Borges TF, Junior MT, Monteiro SAC, Bottacin FS, Mestriner-Junior W, Regalo IH, Siessere S, Semprini M, Regalo SCH. Alterations in masticatory cycle efficiency and bite force in individuals with periodontitis. Int J Health Sci (Qassim). 2019 Jan-Feb;13(1):25-29.

    PMID: 30842715RESULT

  • Olivieri Q, Maniewicz S, Chebib N, Mojon P, Muller F. The Preferred Chewing Side in Partially Edentulous Patients Is More Related to Residual Dentition Than Hemispheric Laterality. J Oral Rehabil. 2025 Jul;52(7):949-956. doi: 10.1111/joor.13955. Epub 2025 Feb 27.

    PMID: 40013481RESULT

  • Ikebe K, Matsuda K, Kagawa R, Enoki K, Okada T, Yoshida M, Maeda Y. Masticatory performance in older subjects with varying degrees of tooth loss. J Dent. 2012 Jan;40(1):71-6. doi: 10.1016/j.jdent.2011.10.007. Epub 2011 Oct 21.

    PMID: 22037296RESULT

  • Barbe AG, Javadian S, Rott T, Scharfenberg I, Deutscher HCD, Noack MJ, Derman SHM. Objective masticatory efficiency and subjective quality of masticatory function among patients with periodontal disease. J Clin Periodontol. 2020 Nov;47(11):1344-1353. doi: 10.1111/jcpe.13364. Epub 2020 Sep 23.

    PMID: 32892357RESULT

  • Ayuso-Montero R, Mariano-Hernandez Y, Khoury-Ribas L, Rovira-Lastra B, Willaert E, Martinez-Gomis J. Reliability and Validity of T-scan and 3D Intraoral Scanning for Measuring the Occlusal Contact Area. J Prosthodont. 2020 Jan;29(1):19-25. doi: 10.1111/jopr.13096. Epub 2019 Jul 21.

    PMID: 31270888RESULT

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

Haitham Elbishari, PhD

CONTACT

+971529131315helbishari@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asscoaite Professor

Study Record Dates

First Submitted

June 26, 2026

First Posted

August 19, 2026

Study Start (Estimated)

October 6, 2026

Primary Completion (Estimated)

January 25, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

August 19, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share