Efficacy of Local Doxycycline Gel Delivery Versus Doxycycline Nanoparticles Prepared Gel in The Treatment of Stage II Periodontitis

NCT06994455 | Active Not Recruiting

• 1 other identifier: A020120230M
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the Efficacy of Local Doxycycline Gel Delivery Versus Doxycycline Nanoparticles Prepared Gel in The Treatment of stage II Periodontitis Materials and methods: forty five patients (n=45) were selected from the Department of Oral Medicine and Periodontology, Faculty of Dentistry, Mansoura University. 45 particpants are classified into 3 groups Group 1(test group): 15 Patients will be treated with doxycycline gel (regular non-nanoparticle form) as an adjunct to mechanical debridement. Group 2 (test group): 15 Patients will be treated with doxycycline-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement. Group 3 (control group): 15 patients will be treated with mechanical debridement only. After proper examination and diagnosis, full mouth supra- and subgingival scaling and root planning will be performed over two weeks (two consecutive days per week) and all periodontitis patients will be treated with ultrasonic scaler and hand instrument for meticulous removal of subgingival and supragingival plaque and calculus. All patients will receive oral hygiene instructions. Gel Application: After completion of scaling and root planning the doxycycline gel will be injected subgingivally in the deepest selected periodontitis pockets of the group 1 and doxycycline-loaded Poly lactic-co-glycolic acid (PLGA) gel in group 2 using a disposable syringe. Care will be taken to apply the gel without traumatizing or damaging the periodontal tissues. Participants will be instructed to refrain from chewing hard or consuming sticky foods, brushing near the treated areas, or using any interdental aids for 1 week. The injection will be applied in the third week with maintenance of good oral hygiene. Periodontal Parameters: Changes in the clinical parameters will be evaluated. For all periodontitis patients, the Clinical assessment will be performed at baseline, after 4 weeks and after 8 weeks from the start of the study. All these clinical parameters will be assessed:

1. 1.Plaque Index according to Silness \& Loe 1964.26
2. 2.Gingival Bleeding Index according to Ainamo \& Bay 1975.27
3. 3.Probing pocket depth (PPD) 28 is measured from free gingival margin to the base of the pocket.
4. 4.Clinical attachment level (CAL) 29 is measured from the cement-enamel junction to the base of the pocket.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (1)

• probing pocket depth reduction

  pocket depth is calculated using periodontal probe to calculate the distance between the base of the pocket to the free gingival margin

  8 weeks

Secondary Outcomes (5)

• plaque index

  8 weeks

• clinical attachment gain

  8 weeks

• gingival bleeding index

  8 weeks

• microbiological detection of p.gingivalis

  8 weeks

• microbiological detection for p.intermedia

  8 weeks

Study Arms (3)

group 1: doxycycline gel+SRP

EXPERIMENTAL

doxycycline gel (regular non-nanoparticle form) as an adjunct to mechanical debridement.

Procedure: scaling and root planing along with antibiotic intervention

group 2: doxycycline-loaded(PLGA) nanoparticles gel +SRP

EXPERIMENTAL

doxycycline-loaded Poly lactic-co-glycolic acid (PLGA) nanoparticles gel as an adjunct to mechanical debridement.

Procedure: scaling and root planing along with antibiotic intervention

group 3: mechanical debridement only.

ACTIVE COMPARATOR

scaling and root planing alone

Procedure: scaling and root planing

Interventions

scaling and root planing along with antibiotic intervention PROCEDURE

doxycycline gel exhibits bacteriostatic activity against prevalent periodontal pathogens

group 1: doxycycline gel+SRP

scaling and root planing PROCEDURE

control group in the study

group 3: mechanical debridement only.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes above 20 years old
• Patients with probing pocket depth ≤ 5 mm.
• No history of antibiotic and periodontal therapy in the last 3 months

You may not qualify if:

• Patients with systemic diseases.
• Pregnant and lactating females.
• Heavy smokers.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura, Egypt, 35516

Al Mansurah, Dakahlia Governorate, 0000, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: May 29, 2025
• Study Start: June 2, 2024
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 29, 2025

Record last verified: 2024-08

Locations

EG (1)