Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis

NCT ID: NCT06772506

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2024-11-30

Brief Summary

Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.

Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.

Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.

Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?

Detailed Description

Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, including the gingiva, periodontal ligament, cementum, and alveolar bone. The advanced stages of periodontitis, such as stage 4, are characterized by severe tissue destruction, deepened pocket depths, and alveolar bone loss, which can ultimately lead to tooth mobility, drifting, and loss. Effective therapeutic interventions are necessary to halt the progression of the disease and potentially regenerate the lost periodontal tissues.

Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.

Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.

Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.

Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?

Conditions

Periodontitis; Stage IV Periodontitis; Minimally Invasive Treatment; Splints

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

conventional periodontal treatment with ultrasonic device and manual instruments

conventional non-surgical techniques with ultrasonic and manual scaler instruments

Group Type: EXPERIMENTAL

Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)

Intervention Type: PROCEDURE

non-surgical technique plus splint and ultrasonic device with 200 mg Tetracycline

Placebo minimally invasive non surgical technique with mini five and after five instruments

and minimally invasive non-surgical technique using mini five and after five instruments+ ultrasonic device for supragingival instrumentation

Group Type: PLACEBO_COMPARATOR

Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint

Intervention Type: PROCEDURE

minimally invasive instruments, with mini five and after five minimally invasive instrument ultrasonic scaler device, conventional radiographic device and periodontal instruments with post-operative 1 gram penicillin for 3 days regulatory Statement: This study does not include an FDA-regulated device intervention, as the tools utilized are not the subject of investigation but are instead employed as part of routine clinical

Interventions

Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)

non-surgical technique plus splint and ultrasonic device with 200 mg Tetracycline

Intervention Type: PROCEDURE

Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint

minimally invasive instruments, with mini five and after five minimally invasive instrument ultrasonic scaler device, conventional radiographic device and periodontal instruments with post-operative 1 gram penicillin for 3 days regulatory Statement: This study does not include an FDA-regulated device intervention, as the tools utilized are not the subject of investigation but are instead employed as part of routine clinical

Intervention Type: PROCEDURE

Other Intervention Names

with ultrasonic device; mini five and after five instruments

Eligibility Criteria

Inclusion Criteria

• periodontitis stage III and IV
• Mobility grade 2
• age from 18-55 years
• medically free
• nonsmoker
• Single-rooted teeth

Exclusion Criteria

• Medically compromised patient
• smokers
• Bad oral hygiene
• Non-surgical or surgical periodontal treatment in the past 12months.
• Prolonged treatment with antibiotics or anti-inflammatory agents within 6months before periodontal therapy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University

OTHER

Sponsor Role: lead

Responsible Party

shaimaa hamdy

lecturer in department of periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Egypt

Cairo, Beni Suweif Governorate, Egypt

Countries

Egypt

Other Identifiers

2019-002239-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MINST in Periodontitis

Identifier Type: -

Identifier Source: org_study_id