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

NCT06772506 | Completed DMC FDA Device

• 2 other identifiers: MINST in Periodontitis2019-002239-27
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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?

Conditions

Periodontitis; Stage IV Periodontitis; Minimally Invasive Treatment; Splints

Keywords

periodontitis; stage IV; MINST; splint

Outcome Measures

Primary Outcomes (1)

• CAL by millimeters

  Clinical attachment loss

  baseline, 3months and 6 months

Study Arms (2)

conventional periodontal treatment with ultrasonic device and manual instruments

EXPERIMENTAL

conventional non-surgical techniques with ultrasonic and manual scaler instruments

Procedure: 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%)

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

PLACEBO COMPARATOR

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

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

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%) PROCEDURE

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

conventional periodontal treatment with ultrasonic device and manual instruments

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

Also known as: with ultrasonic device, mini five and after five instruments

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: 18-55 year old
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

Study Sites (1)

Egypt

Cairo, Beni Suweif Governorate, 12345, Egypt

Location

MeSH Terms

Conditions

Periodontitis

Interventions

Listerine; Ethanol; methyl salicylate; Menthol; Thymol; Splints

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Cyclohexanols; Hexanols; Fatty Alcohols; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: investigator
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer in department of periodontology

Study Record Dates

• First Submitted: January 3, 2025
• First Posted: January 13, 2025
• Study Start: August 11, 2022
• Primary Completion: November 11, 2024
• Study Completion: November 30, 2024
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)