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Non-surgical Periodontal Therapy: Efficacy of re Treatment for Non-responding Sites.

Non-surgical Periodontal Therapy: Efficacy of Repeated Subgingival Instrumentation for Non-responding Sites. A Quasi-experimental Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05297227
Acronym
Nrs_1
Enrollment
63
Registered
2022-03-28
Start date
2022-04-01
Completion date
2023-02-01
Last updated
2022-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non Responding Sites, Periodontal Therapy

Brief summary

The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. They were treated with PMPR and Subgingival Instrumentation according to their diagnosis. After 3 months they will be re-evaluated, and non-responding sites (Ppd\>=4mm and bop+) will be scheduled for the second session of PMPR and SI. After 2 months they will be re-evaluated and clinical efficacy will be defined.

Detailed description

The current experimental protocol is a pre-post quasi-experimental design. A cohort of individuals will be enrolled progressively according to a screening record of periodontitis. Once included, individuals will receive, by a calibrated examiner, a full-mouth periodontal chart, and accordingly, they will be treated in a multi-step approach, in accordance with the recent clinical guidelines. The treatment will consist of oral hygiene instruction and motivation, risk factor control, professional mechanical plaque removal (PMPR), and subgingival instrumentation (SI): it will be performed by two experienced operators. Thereafter, after 3 months, patients will be evaluated and a new periodontal chart will be performed. The presence of non-responding sites (Ppd\>4 and bop+) will be treated with the second session of PMPR plus Subgingival Instrumentation. After 2 months patients will be clinically evaluated and a full periodontal chart will be completed.

Interventions

PROCEDURENon surgical periodontal Therapy

Non-surgical periodontal therapy comprising oral hygiene instruction and motivation, professional mechanical plaque removal, and subgingival instrumentation will be performed. It consists in the use of an ultrasuond (piezoeletric device) and manual curettes.

Sponsors

University of Siena
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* unremarkable general health; age 18-80; minimum of 20 teeth; Periodontitis (Stage 1-4); no antibiotic intake in the previous 6 months;

Exclusion criteria

* Subgingival instrumentation in the previous 12 months * No antibiotic intake in the previous 3 months * A compromised medical condition requiring prophylactic antibiotic coverage * Pregnant/nursing * Ongoing drug therapy that might alter the clinical signs and symptoms of periodontitis

Design outcomes

Primary

MeasureTime frameDescription
Number of pocket closuresthrough study completition, 6 monthsProportion of pathological periodontal pockets (non responding site) that will be closed (Ppd \<5 and bop-) after the second instrumentation

Contacts

Primary ContactNicola Discepoli, Prof.
nicola.discepoli2@unisi.it3395256148

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026