Comparison of Adjunctive Chemomechanical Therapy With Standard Care in Patients With Periodontitis

NCT05757921 | Completed

• 1 other identifier: Peri_Solv
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of the clinical trial is to compare adjunctive chemomechanical therapy with standard care regarding root planning in patients with periodontitis. The primary outcome is to measure pocket depth before and after treatment in the test, and control group respectively Secondary outcomes:

• Bleeding on probing
• Plaque index
• Quality of life from standardized protocol The hypothesis is that non- surgical mechanical treatment with chloramines in patients with periodontitis will show a better pocket closure after the treatment.

Conditions

Periodontitis

Keywords

probing pocket depth; bleeding on probing; dental plaque

Outcome Measures

Primary Outcomes (3)

• probing pocket depth

  millimeter

  baseline

• probing pocket depth

  millimeter

  3 months

• probing pocket depth

  millimeter

  12 months

Secondary Outcomes (6)

• bleeding on probing

  baseline

• bleeding on probing

  3 months

• bleeding on probing

  12 months

• plaque index

  baseline

• plaque index

  3 months

Study Arms (2)

Non-surgical mechanical treatment with Perisolv® (A)

EXPERIMENTAL

The test group will receive the following treatment: In the deepened pockets to be treated, Perisolv is initially applied according to the manufacturers recommendation.Then subgingival debridement is performed. This is performed with piezoelectric ultrasound (EMS) while rinsing water and completed with subgingival manual instrumentation. In addition an aliquot of Perisolv was left after final debridement.

Device: Perisolv (A)

Non-surgical mechanical treatment without Perisolv® (B)

ACTIVE COMPARATOR

The control group will receive the following treatment: In the deepened pockets to be treated, subgingival debridement is performed. This is performed with piezoelectric ultrasound (EMS) while rinsing water and completed with subgingival manual instrumentation.

Other: Standard (B)

Interventions

Perisolv (A) DEVICE

Intended for cleaning periodontal pockets for both periodontitis and peri-implantitis. Softens degenerative tissue and biofilm before depuration of periodontal pockets. Does not affect healthy tissue.

Non-surgical mechanical treatment with Perisolv® (A)

Standard (B) OTHER

Deepened periodontal pockets to be treated are performed by subgingivally debridement. This is performed with piezoelectric ultrasound (EMS) under rinsing water and subgingival debridement with hand instrument.

Non-surgical mechanical treatment without Perisolv® (B)

Eligibility Criteria

• Age: 23 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who agree to participate in the study and who also have at least 4 gingival pockets with probing depth ≥5 mm and which at the same time bleed on probing.

You may not qualify if:

• Individuals with uncontrolled/difficult diabetes mellitus (HbA1c \> 7.0)
• Individuals who need antibiotic prophylaxis
• Individuals taking medication with Prednisolone.
• Individuals taking medication that has a known side effect, gingival hyperplasia
• Individuals who took systemic antibiotics 3 months before the start of the study.

Sponsors & Collaborators

• Kristianstad University: lead

Related Publications (7)

• Smiley CJ, Tracy SL, Abt E, Michalowicz BS, John MT, Gunsolley J, Cobb CM, Rossmann J, Harrel SK, Forrest JL, Hujoel PP, Noraian KW, Greenwell H, Frantsve-Hawley J, Estrich C, Hanson N. Systematic review and meta-analysis on the nonsurgical treatment of chronic periodontitis by means of scaling and root planing with or without adjuncts. J Am Dent Assoc. 2015 Jul;146(7):508-24.e5. doi: 10.1016/j.adaj.2015.01.028.

  PMID: 26113099 BACKGROUND

• Ferreira MC, Dias-Pereira AC, Branco-de-Almeida LS, Martins CC, Paiva SM. Impact of periodontal disease on quality of life: a systematic review. J Periodontal Res. 2017 Aug;52(4):651-665. doi: 10.1111/jre.12436. Epub 2017 Feb 8.

  PMID: 28177120 BACKGROUND

• Citterio F, Gualini G, Chang M, Piccoli GM, Giraudi M, Manavella V, Baima G, Mariani GM, Romano F, Aimetti M. Pocket closure and residual pockets after non-surgical periodontal therapy: A systematic review and meta-analysis. J Clin Periodontol. 2022 Jan;49(1):2-14. doi: 10.1111/jcpe.13547. Epub 2021 Nov 11.

  PMID: 34517433 BACKGROUND

• Jepsen K, Jepsen S. Antibiotics/antimicrobials: systemic and local administration in the therapy of mild to moderately advanced periodontitis. Periodontol 2000. 2016 Jun;71(1):82-112. doi: 10.1111/prd.12121.

  PMID: 27045432 BACKGROUND

• Guida A. Mechanism of action of sodium hypochlorite and its effects on dentin. Minerva Stomatol. 2006 Sep;55(9):471-82. English, Italian.

  PMID: 17146426 BACKGROUND

• Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Periodontol. 2018 Jun;89 Suppl 1:S173-S182. doi: 10.1002/JPER.17-0721.

  PMID: 29926951 BACKGROUND

• Wallin-Bengtsson V, Scherdin-Almhojd U, Roos-Jansaker AM. Supra- and sub-gingival instrumentation of periodontitis with the adjunctive treatment of a chloramine - a one-year randomized clinical trial study. Acta Odontol Scand. 2024 Mar 22;83:1-6. doi: 10.1080/00016357.2023.2281486.

  PMID: 37962876 DERIVED

MeSH Terms

Conditions

Periodontitis; Dental Plaque

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Study Officials

• Ann-Marie AJ Roos Jansaker, Assoc.Prof.

  Kristianstad University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Principal investigator and investigator (the periodontologists) were calibrated prior to the study. Outcome assessments were performed separately by the periodontologists and blinded. The statisticians were also blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Test group: non-surgical mechanical treatment and adjunctive treatment Perisolv Control group: non-surgical mechanical treatment

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 7, 2023
• Study Start: October 24, 2011
• Primary Completion: May 16, 2014
• Study Completion: May 16, 2014
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share