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

January 11, 2025 updated by: shaimaa hamdy, Minia University

Clinical and Patient-centered Outcomes After Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis - Randomized Controlled Clinical Trial

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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?

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Beni Suef
      • Cairo, Beni Suef, Egypt, 12345
        • Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: conventional periodontal treatment with ultrasonic device and manual instruments
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%)
non-surgical technique plus splint and ultrasonic device with 200 mg Tetracycline
Placebo Comparator: 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
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
Other Names:
  • with ultrasonic device
  • mini five and after five instruments

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CAL by millimeters
Time Frame: baseline, 3months and 6 months
Clinical attachment loss
baseline, 3months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2022

Primary Completion (Actual)

November 11, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

January 3, 2025

First Submitted That Met QC Criteria

January 10, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 11, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MINST in Periodontitis
  • 2019-002239-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

after publishing, i will share it

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Periodontitis

Clinical Trials on 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%)

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