NCT07472218

Brief Summary

This study aims to evaluate and compare the efficacy of two different eugenol-free periodontal dressing materials-Ora-Aid (a hydrophilic polymer) and Coe-Pak (a zinc oxide-based paste)-following non-surgical periodontal treatment (scaling and root planing, SRP) in patients with Stage 3, Grade A periodontitis. The study utilizes a split-mouth design to analyze clinical periodontal parameters, patient comfort, and microbiological changes over a 3-month period.

Trial Health

65
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
2mo left

Started Apr 2026

Shorter than P25 for not_applicable

Status
not yet 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 Progress67%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

February 24, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 16, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

6 months

First QC Date

February 24, 2026

Last Update Submit

March 13, 2026

Conditions

PeriodontitisPeriodontitis (Stage 3)Periodontal Pocket

Keywords

periodontitisNon-surgical periodontal therapyPeriodontal dressingOra-AidCoe-Paktotal bacterial load

Outcome Measures

Primary Outcomes (2)

  • Change in Probing Pocket Depth (PPD)

    PPD will be measured at six sites per tooth using a calibrated periodontal probe. The mean value per patient will be calculated. A decrease in PPD indicates clinical improvement. Unit of Measure: Millimeters (mm)

    Baseline, 1st and 3rd months

  • total bacterial load

    This study involves the longitudinal comparison of total bacterial load, assessed via plaque samples collected from the deepest periodontal pockets on both the right and left sides at baseline, 1 month, and 3 months post-treatment.

    baseline, 1 month, and 3 months

Secondary Outcomes (4)

  • Evoluation of Gingival Index (GI)

    Baseline, 1st and 3rd months.

  • Plaque Index (PI) Scores

    Baseline, 1 month, 3 months.

  • Percentage of Sites with Bleeding on Probing (BOP)

    Baseline, 1 month, 3 months.

  • Change in Clinical Attachment Loss (CAL)

    Baseline, 1 month, 3 months.

Study Arms (2)

Ora-aid side

EXPERIMENTAL

A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week.

Procedure: Coe-Pack application

Coe-pack side

EXPERIMENTAL

A split-mouth study design has been planned for the same patient. The patient's right or left upper and lower jaws will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth scaling and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the dressings are in place. The wound dressings will be removed after 1 week.

Procedure: Ora Aid application

Interventions

Ora Aid applicationPROCEDURE

Baseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis. Intervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants. 1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites. 1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR. 3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains.

Coe-pack side
Coe-Pack applicationPROCEDURE

Baseline: Comprehensive periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) will be recorded. Subgingival plaque samples will be collected from the deepest periodontal pockets for microbiological analysis. Intervention: Following full-mouth scaling and root planing (SRP), Ora-Aid or Coe-Pak dressings will be applied to the designated quadrants. 1-Week Follow-up: Periodontal dressings will be professionally removed from all treated sites. 1-Month Follow-up: Periodontal clinical indices will be re-evaluated. Plaque samples will be collected from the same initial sites to determine changes in total bacterial load via qPCR. 3-Month Follow-up: Final periodontal clinical measurements will be recorded to assess long-term treatment efficacy and clinical attachment gains

Ora-aid side

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Systemically healthy volunteers aged 18-45 years.
  • Diagnosis of Periodontitis (Stage 3, Grade A).
  • Presence of at least 20 permanent teeth.
  • Capacity to understand the study protocol and provide informed consent.

You may not qualify if:

  • Systemic diseases (e.g., Diabetes, Chronic Renal Failure, Cancer, Connective Tissue Disorders).
  • Pregnancy or breastfeeding.
  • Smoking (\>10 cigarettes/day).
  • Antibiotic use within the last 3 months or periodontal treatment within the last year.
  • Presence of orthodontic appliances, removable prostheses, or extensive interproximal caries.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PeriodontitisPeriodontal Pocket

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Central Study Contacts

SEVAL CEYLAN ŞEN, Assist Prof

CONTACT

+905333161232dt.sceylan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The primary investigator responsible for clinical data collection and sample procurement is masked to the treatment allocation. Specifically, the examiner performing the periodontal measurements (GI, PI, PBI, BOP, PPD, and CAL) and collecting the subgingival plaque samples at baseline, 1 month, and 3 months is blinded to which quadrants received the Ora-Aid or Coe-Pak dressings. To maintain this blinding, the dressings are removed by a separate clinician one week post-treatment, ensuring that the examining researcher has no knowledge of the intervention assigned to each split-mouth site during the follow-up evaluations.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study Group (Total n=25): A split-mouth study design was planned for the same patient. The right or left upper and lower jaws of the patients will be covered with Ora-Aid or periodontal paste after initial periodontal treatment. Which side will receive Ora-Aid and which side will receive periodontal paste will be determined by a coin toss. After full mouth tooth surface cleaning and root planing in the same session, Ora-Aid wound dressing or periodontal pat will be applied to the 1st and 3rd quadrants. Patients will be given oral hygiene instructions and asked to avoid brushing the periodontal dressing area while the periodontal dressings are in place. Patients' wound dressings will be removed after 1 week. Patients who applied to the Department of Periodontology, Gülhane Dental School, Health Sciences University, and were diagnosed with periodontitis (Stage 3-Grade A) during the clinical examination and underwent routine non-surgical periodontal treatment will be included in the study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 24, 2026

First Posted

March 16, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 16, 2026

Record last verified: 2026-03