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Pain perception during Cleaning of dental roots in patients with systemic chronic diseases using Local Anesthesia

Pain perception during Scaling and Root Planing in patients with systemic chronic diseases using Local Anesthesia - SRPPCD: Scaling and Root Planing in Patients with Chronic Diseases

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
REBEC
Registry ID
RBR-9d8cxh
Enrollment
Unknown
Registered
2019-10-03
Start date
2019-06-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Chronic Periodontitis

Interventions

Intervention: Non-surgical periodontal treatment, local anesthesia. 4 studies will be elaborated: Study 1: Number of Participants (n) = 40. Volunteers in this study will undergo non-surgical periodont
2. LID (4% lidocaine cream)
3.LIP (2.5% lidocaine cream + 2.5% prilocaine) in a split mouth experimental model, so each volunteer will undergo different interventions (noninvasive anesthesia) with a 1 week interval between them.
2. IS: sonic instrumentation
3. UI: ultrasonic instrumentation. The instrumentation of each quadrant will be performed every 1 week, regardless of the anesthetic technique used. Study 4 (n = 80, same volunteers included in studie
2. AC (c
Drug
Procedure/surgery
E03.155.086.231

Sponsors

Curso de Odontologia - Universidade Estadual de Ponta Grossa
Lead Sponsor
Universidade Estadual de Ponta Grossa
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with mild to severe localized / generalized periodontal disease (stage I to IV, classification 2018) with 4 sites with probing depth measurements greater than 4mm in at least two teeth per quadrant, with clinical attachment loss greater than 1mm, presence of supra and subgingival calculus and / or dental biofilm as well as presence of bleeding on probing and / or marginal suppuration; over 18 years old; being under medical supervision due to chronic diseases (pulmonary, cardiovascular and metabolic).

Exclusion criteria

Exclusion criteria: Patients in periodontal or orthodontic maintenance; history of allergy, sensitivity or any form of allergic reaction to amide-based anesthetics; pregnant or lactating women; patients with severe uncontrolled systemic disease and without specialized medical follow-up; psychiatric problems that may interfere with scaling and root planing or administration of topical anesthetics and injectables; local pathological alterations such as presence of ulcerative lesions, abscesses, acute infections; volunteers who require dental extraction in the selected quadrants; need for antibiotic prophylaxis prior to treatment; patients who used analgesic and anti-inflammatory drugs within 12 hours prior to treatment; individuals with a history of alcoholism; smokers; dentin hypersensitivity or other pulp pathologies that may interfere in the measurement of the data in the teeth involved in the research.

Design outcomes

Primary

MeasureTime frame
Expected outcome 1: Noninvasive anesthesia is expected to be effective in controlling pain and discomfort during non-surgical periodontal treatment. Verified by the 101-point numerical scale (NRS-101) and the 4-point verbal scale (VRS-4), where values closer to zero indicate lower pain intensity, significance level adopted will be 5%. Data collected immediately after each session of scaling and root planing.;Expected outcome 2: Lidocaine and prilocaine infiltrative anesthesia are expected to be as effective as articaine anesthesia in controlling pain and discomfort during non-surgical periodontal treatment. Verified through the NRS-101 and VRS-4 scales, assuming a minimum difference of 15% as not significant. Data collected immediately after each session of scaling and root planing.;Expected outcome 3: It is expected that there will be no difference in pain and discomfort perception during non-surgical periodontal treatment using manual, sonic or ultrasonic instruments. Verified through the NRS-101 and VRS-4 scales, assuming a minimum difference of 15% as not significant. Data collected immediately after each session of scaling and root planing.;Expected outcome 4: Noninvasive anesthesia is expected to be as effective as conventional anesthesia for pain and discomfort control during non-surgical periodontal treatment. Verified through the NRS-101 and VRS-4 scales, assuming a minimum difference of 15% as not significant. Data collected immediately after each session of scaling and root planing.

Secondary

MeasureTime frame
It is expected to observe improvement in the quality of life of volunteers, verified through the Oral Health Impact Profile (OHIP-14) questionnaire, where lower scores indicate better quality of life, significance level adopted will be 5%. Data collected before the intervention and after 3 months.;It is expected that anesthetics used for non-surgical periodontal treatment do not change hemodynamic parameters. Systemic and intracranial blood pressure will be measured, respectively, by automatic digital pressure device and noninvasive equipment. Data collected prior to care, soon after the end of the anesthetic technique and after the conclusion of the scraping and root planing session.;It is expected to observe improvement of the periodontal condition. Verified by assessing periodontal parameters (marginal suppuration, visible plaque, gingival recession, clinical probing depth, bleeding on probing, and clinical attachment loss) using a millimeter periodontal probe, adopted significance level will be 5%. Data collected before the intervention and after 3 months.;It is expected to observe an improvement in masticatory performance, verified by the Optosil cube masticatory method, adopted significance level will be 5%. Data collected before the intervention and after 3 months.

Countries

Brazil

Contacts

Public ContactFábio dos Santos

Universidade Estadual de Ponta Grossa

fasantos11@gmail.com+55 (42) 32203104

Outcome results

None listed

Source: REBEC (via WHO ICTRP)