Treatment of patients with severe periodontal disease by common periodontal cleaning or with surgery using an ultrasound device

Surgical and non-surgical treatment of periodontitis with ultrasonic debridement: a controlled randomized clinical trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

REBEC

Registry ID

RBR-66vrz8

Enrollment

Unknown

Registered

2020-04-03

Start date

2012-08-01

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

The experimental clinical protocol was performed 21 days after initial periodontal therapy that made by another operator properly calibrated. This protocol included antisepsis intra and extra-oral wit

Procedure/surgery

E06.721.189.350

E06.721.189.675

E06.721.874

E06.892

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with diagnostic of chronic periodontitis, by presence of periodontal pockets with clinical attachment loss of 5 mm, with bleeding on probing, radiographic evidence of bilateral intrabony defect limited to two or three walls determined by periapical radiographs, and the absence of a medical condition that could affect the progression of periodontal disease.

Exclusion criteria

Exclusion criteria: Pregnant or lactating; smokers; Patients who required antibiotic premedication; patients who received antibiotic treatment in the previous 6 months; patients who received a course of periodontal treatment within the past 6 months; tooth with furcation involvements; tooth with endodontic treatment and non-vital tooth; tooth presenting mobility and/or traumatic occlusion.

Design outcomes

Primary

Measure	Time frame
Expected outcome 1: gain or loss of insertion verified through the relative level of clinical insertion, which was assessed from the base of the stent to the bottom of the periodontal pocket at the beginning of the study (21 days after the initial phase), 3 and 6 months after therapy by the same blind and calibrated examiner, using a standardized periodontal probe with 1-mm markings (PCPUNC 15, Hu-Friedy, Chicago, IL, USA) with a stent fabricated on acrylic guide (Bio-art, São Carlos, SP, Brazil) of probing to standardize the location and angulation of periodontal probes at the defects sites. ;Outcome found 1: In the study, gain of insertion was found at 3 and 6 months in the control and test groups (p 0.05).	—

Measure

Time frame

Expected outcome 1: gain or loss of insertion verified through the relative level of clinical insertion, which was assessed from the base of the stent to the bottom of the periodontal pocket at the beginning of the study (21 days after the initial phase), 3 and 6 months after therapy by the same blind and calibrated examiner, using a standardized periodontal probe with 1-mm markings (PCPUNC 15, Hu-Friedy, Chicago, IL, USA) with a stent fabricated on acrylic guide (Bio-art, São Carlos, SP, Brazil) of probing to standardize the location and angulation of periodontal probes at the defects sites. ;Outcome found 1: In the study, gain of insertion was found at 3 and 6 months in the control and test groups (p 0.05).

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Secondary

Measure	Time frame
Expected outcome 6: reduction in the bone defect level (BDL) measured from the distance between the top of the alveolar bone crest and the base of the intraosseous defect and in the area of the defect (AD). All measurements were expressed as mean ± SD in relation to the length of the tooth to correct geometric differences in the pre- and postoperative radiographs. All were performed at baseline and 6 months post therapy with the aid of image analysis software (Image Tool 3.0, Media Cybernetics, Silver Spring, MD, USA). For use in this software, all images were placed in grayscale using a Microsoft Power-point program. The same blind examiner of the clinical parameters made the radiographic measurements from the measurements in mm of a ruler photographed with the radiography.;Outcome found 6: In the study statistically significant reductions of the area of the defect and the bone defect level were observed in 6 months (p0.05). ;Expected outcome 7: reduction in the discomfort and / or pain experienced during therapy. They were evaluated at the end of the experimental procedures using a questionnaire answered by the patients. The extent of discomfort and / or pain experienced during the intra-therapy period was assessed using a 100 mm horizontal visual analog scale (VAS) of 100 mm, with zero as complete absence of pain / discomfort and 100 as extreme / intolerable pain / discomfort.;Outcome found 7: Patient-oriented outcomes demonstrated lower discomfort/pain experience in control group in the first and second days (p0.05).;Expected outcome 2: increase, appearance or reduction of gingival recessions, measured from the base of the stent to the gingival margin at the beginning of the study (21 days after the initial phase), 3 and 6 months after therapy by the same blind and calibrated examiner, using a standardized periodontal probe with 1-mm markings (PCPUNC 15, Hu-Friedy, Chicago, IL, USA) with a stent fabricated on acrylic guide (Bio-art, São Carlos, SP, Brazil) of pr	—

Measure

Time frame

Expected outcome 6: reduction in the bone defect level (BDL) measured from the distance between the top of the alveolar bone crest and the base of the intraosseous defect and in the area of the defect (AD). All measurements were expressed as mean ± SD in relation to the length of the tooth to correct geometric differences in the pre- and postoperative radiographs. All were performed at baseline and 6 months post therapy with the aid of image analysis software (Image Tool 3.0, Media Cybernetics, Silver Spring, MD, USA). For use in this software, all images were placed in grayscale using a Microsoft Power-point program. The same blind examiner of the clinical parameters made the radiographic measurements from the measurements in mm of a ruler photographed with the radiography.;Outcome found 6: In the study statistically significant reductions of the area of the defect and the bone defect level were observed in 6 months (p0.05). ;Expected outcome 7: reduction in the discomfort and / or pain experienced during therapy. They were evaluated at the end of the experimental procedures using a questionnaire answered by the patients. The extent of discomfort and / or pain experienced during the intra-therapy period was assessed using a 100 mm horizontal visual analog scale (VAS) of 100 mm, with zero as complete absence of pain / discomfort and 100 as extreme / intolerable pain / discomfort.;Outcome found 7: Patient-oriented outcomes demonstrated lower discomfort/pain experience in control group in the first and second days (p0.05).;Expected outcome 2: increase, appearance or reduction of gingival recessions, measured from the base of the stent to the gingival margin at the beginning of the study (21 days after the initial phase), 3 and 6 months after therapy by the same blind and calibrated examiner, using a standardized periodontal probe with 1-mm markings (PCPUNC 15, Hu-Friedy, Chicago, IL, USA) with a stent fabricated on acrylic guide (Bio-art, São Carlos, SP, Brazil) of pr

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Countries

Brazil

Contacts

Public ContactCamila de Oliveira

Universidade Federal de Goiás

costa.c.alves@gmail.com+55 62 981723441

Outcome results

None listed

Source: REBEC (via WHO ICTRP)