Health TrialsbyHealthPanel

Periodontal Dressings in Non-Surgical Therapy

ConditionsPeriodontitisPeriodontitis (Stage 3)Periodontal Pocket
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorSaglik Bilimleri Universitesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ora Aid application

    Procedure/Surgery

    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 application

    Procedure/Surgery

    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

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Ora-aid sideExperimental treatment 1 intervention
Group B: Coe-pack sideExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
Baseline, 1st and 3rd months
2

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.

Time frame
baseline, 1 month, and 3 months

Secondary outcomes

1

Evoluation of Gingival Index (GI)

Gingival inflammation will be assessed using the Loe and Silness Gingival Index. Scores range from 0 to 3 (0 = Normal gingiva; 3 = Severe inflammation, ulceration, tendency to spontaneous bleeding). Unit of Measure: Units on a scale (Score 0-3)

Time frame
Baseline, 1st and 3rd months.
2

Plaque Index (PI) Scores

Oral hygiene status will be assessed using the Silness and Loe Plaque Index. Scores range from 0 to 3 (0 = No plaque; 3 = Abundance of soft matter). Unit of Measure: Units on a scale (Score 0-3)

Time frame
Baseline, 1 month, 3 months.
3

Percentage of Sites with Bleeding on Probing (BOP)

Presence or absence of bleeding will be recorded within 30 seconds after probing. The result will be expressed as the percentage of total sites that bleed. Unit of Measure: Percentage of sites (%)

Time frame
Baseline, 1 month, 3 months.
4

Change in Clinical Attachment Loss (CAL)

CAL is measured as the distance from the cemento-enamel junction to the bottom of the periodontal pocket. The mean value per patient will be recorded. Unit of Measure: Millimeters (mm)

Time frame
Baseline, 1 month, 3 months.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saglik Bilimleri Universitesi

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: