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

NCT06772506 — Not applicable, Completed, 40 participants, Minia University

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

RegistryNCT06772506
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: triple, treatment
Enrollment40 (Actual)
SponsorMinia University (Other)
ConditionsPeriodontitis, Stage IV Periodontitis, Minimally Invasive Treatment, Splints
InterventionsNon 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%), Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint (Procedure)
Datesstart 2022-08-11, primary completion 2024-11-11, completion 2024-11-30, first posted 2025-01-13, last updated 2025-01-14
Locations1 site in Egypt

Related Papers Related Patents Related Grants Related Experts
All trials for Periodontitis All trials for Stage IV Periodontitis All trials of 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%) All trials of Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint

-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?

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+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?

+Arms and interventions

ArmTypeInterventionsDescription
conventional periodontal treatment with ultrasonic device and manual instrumentsExperimentalProcedure: 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%)conventional non-surgical techniques with ultrasonic and manual scaler instruments
Placebo minimally invasive non surgical technique with mini five and after five instrumentsPlacebo comparatorProcedure: Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splintand minimally invasive non-surgical technique using mini five and after five instruments+ ultrasonic device for supragingival instrumentation
  • 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
  • Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint (Procedure), also known as with ultrasonic device, mini five and after five instruments: 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

+Outcome measures

Primary outcomes

  • CAL by millimeters [baseline, 3months and 6 months]: Clinical attachment loss

+Eligibility

Sex: All, ages: 18 Years to 55 Years

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.

+Locations (1)

FacilityCityCountryStatus
EgyptCairo, Beni Suweif GovernorateEgypt

+Publications

  • Results publication: Hamdy S, Turky M, Gamal AY. Does minimally invasive non-surgical therapy improve outcomes in splinted mandibular incisors? Results from a randomized trial. BMC Oral Health. 2026 Jun 5;26(1):1192. doi: 10.1186/s12903-026-08788-4. PMID 42249403

+Funding

NIH grants: 2019