Effect of Periodontitis Treatment on Quality of Life and Experiences of Fear, Anxiety and Pain

NCT02409966 | Completed

• 3 other identifiers: 552264/2011-3521-10CAAE 07172212.3.0000.514
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

There are different protocols to treat gum diseases. One relevant differential aspect is related to time. There are protocols that usually takes one to two months to be completed while other are completed within 24 hours. Although both protocols seem to provide clinically similar improvements, there are some positive aspects related to the short-term one. Among them lower number of clinical sessions, easier schedule and costs advantages. However, there are many other relevant aspects that can be helpful for patients and clinicians decisions regarding type of treatment. This study evaluates if and how clinically effective protocols used to treat periodontitis affect quality of life related to individual's oral statuses. In addition, the experiences of fear, anxiety and pain before and after these specific protocols are monitored.

Conditions

Periodontitis

Keywords

periodontitis; therapeutics; quality of life; fear; anxiety; pain

Outcome Measures

Primary Outcomes (3)

• Oral health related quality of life

  changes in OIDP and OHQoL scores from baseline to 6 months

• Scale of self-reported pain

  changes in VAS scores from baseline to 1 month

• Fear and anxiety

  changes in DFS and DAS scores from baseline to 6 months

Other Outcomes (1)

• Periodontal pocket depth (mm) and clinical attachment level (mm) were measure at baseline and at 6 months after active periodontal treatment.

  from baseline to 6 months

Study Arms (2)

Quadrant-wise scaling

ACTIVE COMPARATOR

Patients underwent quadrant scaling under local anesthesia in four weekly sections.

Procedure: Quadrant-wise scaling

Full-mouth 24-hour scaling

EXPERIMENTAL

Patients underwent full-mouth scaling under local anesthesia in two sections within 24 hours.

Procedure: Full-mouth 24-hour scaling

Interventions

Quadrant-wise scaling PROCEDURE

Patients underwent quadrant scaling under local anesthesia in four weekly sections. Three experienced trained periodontists carried out debridement procedures of both protocols with manual Gracey and McCall curettes and Hirschfield files. Oral hygiene instructions were given for all participants and oral supplies were provided for the duration of the study.

Quadrant-wise scaling

Full-mouth 24-hour scaling PROCEDURE

Patients underwent full-mouth scaling under local anesthesia in two sections within 24 hours. Three experienced trained periodontists carried out debridement procedures of both protocols with manual Gracey and McCall curettes and Hirschfield files. Oral hygiene instructions were given for all participants and oral supplies were provided for the duration of the study.

Full-mouth 24-hour scaling

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• mild to moderate chronic periodontitis
• smokers or non-smokers
• at least 18 natural teeth

You may not qualify if:

• regular use or use in the previous 3 months of antibiotics or anti-inflammatory drugs
• regular use (twice a day) of mouthwashes
• sensitivity or allergy to oral hygiene products
• patients undergoing periodontal therapy including dental scaling and root planing procedures in the 12 months preceding the start of the study
• bifurcation or trifurcation class III lesions
• the need for antibiotic prophylaxis for periodontal clinical examination/treatment
• removable partial dentures, fixed or removable orthodontic devices
• pregnancy and lactation
• medical or psychological disorder that could affect the ability of the questionnaires' understanding

Sponsors & Collaborators

• University of Taubate: lead

MeSH Terms

Conditions

Periodontitis; Anxiety Disorders; Pain

Interventions

Tooth Exfoliation

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2015
• First Posted: April 7, 2015
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 23, 2019

Record last verified: 2019-07