NCT07485946

Brief Summary

This retrospective observational study aims to develop treatment-specific machine learning models for predicting tooth-level periodontal treatment outcomes among teeth treated with non-surgical periodontal treatment, conventional flap surgery, or regenerative periodontal surgery. The study uses a multidimensional dataset including baseline clinical periodontal parameters, radiographic findings, documented treatment modalities, and patient-level demographic and clinical characteristics. The analytical unit of the study is the tooth. Only periodontally involved teeth with complete baseline and follow-up clinical records, radiographic assessment, clearly documented treatment modality, and measurable periodontal outcomes are included in the predictive analyses. Full-mouth periodontal information is used for patient-level disease characterization, including periodontal staging and grading according to the 2017 AAP/EFP classification. Because treatment allocation was not randomized, the models are intended to support treatment-specific outcome prediction and clinical interpretability rather than to establish causal superiority between treatment modalities.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

August 2, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 2026

Completed
Last Updated

July 7, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

March 17, 2026

Last Update Submit

July 3, 2026

Conditions

Keywords

periodontitismachine learningclinical decision support system

Outcome Measures

Primary Outcomes (1)

  • Tooth-level Clinical Success of Periodontal Treatment

    Binary tooth-level classification of periodontal treatment outcome as clinical success or clinical failure after completion of active periodontal therapy. The outcome was assessed for each eligible periodontally treated tooth by comparing baseline (T0) and final follow-up (T1) clinical records. Tooth-level clinical treatment success was defined as the simultaneous presence of residual probing pocket depth (PPD) ≤4 mm and absence of bleeding on probing (BOP) at the T1 (final follow-up) examination. As a secondary, machine-learning-oriented outcome, treatment response was categorized using a ≥50% relative reduction in PPD between baseline (T0) and final follow-up (T1), with cases meeting this threshold labeled 'high responders. This primary clinical outcome was analyzed separately from the machine-learning classification outcome based on the ≥50% probing pocket depth reduction threshold.

    Baseline and final post-treatment follow-up after completion of active periodontal therapy; 12 to 48 months.

Study Arms (3)

Phase-1 Periodontal Therapy

Patients who received non-surgical periodontal treatment consisting of oral hygiene instructions, scaling, and root planing (SRP).

Procedure: Phase-1 Periodontal Therapy

Conventional Flap Surgery

Patients who underwent traditional periodontal flap surgery (access flap) following unsuccessful non-surgical therapy to reduce pocket depth.

Procedure: Conventional Flap Surgery

Regenerative Flap Surgery

Patients who underwent periodontal surgery involving regenerative materials (bone grafts, membranes, or enamel matrix derivatives) for the treatment of intrabony defects.

Procedure: Regenerative Flap Surgery

Interventions

Periodontal access flap surgery performed for subgingival debridement and pocket depth reduction in cases unresponsive to Phase-1 therapy.

Conventional Flap Surgery

Surgical intervention utilizing regenerative materials such as bone grafts or barrier membranes for the treatment of periodontal intrabony defects.

Regenerative Flap Surgery

Non-surgical periodontal treatment consisting of scaling and root planing (SRP) under local anesthesia, along with oral hygiene instructions

Phase-1 Periodontal Therapy

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study population consists of patients diagnosed with periodontitis who attended the Department of Periodontology, Faculty of Dentistry, Akdeniz University, between 2021 and 2025. Patients were identified retrospectively from archived clinical and radiographic records. Eligible patients had completed active periodontal therapy and had complete baseline and follow-up records. The analytical unit was the tooth; only periodontally involved teeth with documented treatment modality and measurable treatment outcomes were included in the predictive analyses.

You may qualify if:

  • Patients with a confirmed diagnosis of periodontitis according to the 2017 AAP/EFP classification, supported by complete clinical and radiographic records.
  • Availability of baseline clinical periodontal examination and radiographic records before periodontal treatment.
  • Completion of active periodontal therapy, including non-surgical periodontal treatment and/or surgical periodontal treatment when clinically indicated.
  • Availability of at least one post-treatment follow-up visit after completion of active periodontal therapy.
  • Presence of at least one periodontally involved tooth meeting tooth-level eligibility criteria.
  • Availability of detailed tooth-level documentation, including baseline periodontal measurements, radiographic assessment, documented treatment modality, and corresponding post-treatment outcome records.
  • Teeth were eligible for tooth-level analysis if they received one of the predefined periodontal treatment modalities: non-surgical periodontal treatment, conventional flap surgery, or regenerative periodontal surgery.
  • Patients with a previous history of cancer were eligible if chemotherapy or radiotherapy had been completed and medical clearance for periodontal treatment had been obtained.

You may not qualify if:

  • Incomplete demographic, clinical, radiographic, treatment, or follow-up records.
  • Unclear or undocumented periodontal treatment modality.
  • Systemic conditions contraindicating periodontal treatment or substantially affecting periodontal treatment outcomes.
  • Pregnancy or breastfeeding at the time of periodontal treatment.
  • Ongoing chemotherapy or radiotherapy.
  • Current or previous bisphosphonate therapy affecting periodontal or surgical treatment eligibility.
  • Presence of an immunocompromised condition.
  • Acute systemic illness or active infection at the time of periodontal evaluation or treatment.
  • Teeth with missing baseline or follow-up periodontal measurements, missing radiographic assessment, unclear treatment allocation, or insufficient documentation for outcome assessment were excluded from the tooth-level analysis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, konyaaltı, 07070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 17, 2026

First Posted

March 20, 2026

Study Start

August 2, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

July 7, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations