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Effectiveness of Additional Treatments for Periodontitis: Clinical Study

Efficacy of Adjuvant Therapies in non-surgical and surgical Periodontal Treatment: a randomized, controlled, clinical study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-2rfyjxx
Enrollment
Unknown
Registered
2026-01-19
Start date
2024-03-05
Completion date
Unknown
Last updated
2026-02-02

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

Conditions

Diabetes Mellitus

Interventions

Group Gel - Scaling and root planing and application of gel with green tea extract (0.5%) and hyaluronic acid (0.05%)
This is a randomized, controlled clinical study with 3 proposals. In proposal 1 (split-mouth model clinical study), 90 participants diagnosed with stage II to IV grade A-C periodontitis will be divide
Group D (n=30): participants with decompensated diabetes
and Group F (n=30): smoking participants). The four quadrants (containing at least 2 non-adjacent interproximal sites with probing depth =5 mm and clinical attachment level =3 mm and bleeding on prob
Group aPDT - Scaling and root planing and irrigation with 1 ml of toluidine blue solution (100 µg/ml) followed by application of low-level laser therapy after 1 min
Group aPDT + Gel - Scaling and root planing followed by application of aPDT and Gel. In proposal 2 (split-mouth model clinical study), 90 participants diagnosed with stage II to IV grade A or B period
Group O: irrigation with 10 ml of ozonized water, Group CLX: Scaling and root planing and irrigation with 10 ml of 0.2% chlorhexidine, and Group B: Scaling

Sponsors

Hospital Odontológico da Universidade Federal de Uberlândia
Lead Sponsor
Faculdade de Odontologia da Universidade Federal de Uberlândia
Collaborator

Eligibility

Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: For proposals 1 and 2, participants in the first group must be between 18 and 70 years of age; be diagnosed with periodontitis stages II to IV (moderate to severe), grade A to C; with at least two non-adjacent interproximal sites presenting a probing depth greater than or equal to five millimeters; a clinical attachment level greater than or equal to three millimeters and bleeding on probing in all four quadrants; as well as a minimum of fifteen natural teeth. Participants in the second group must present a diagnosis of uncontrolled type 2 diabetes mellitus, with glycated hemoglobin levels greater than or equal to 7%. Participants in the third group must smoke ten or more cigarettes per day for at least three years. For proposal 3, participants must present maxillary and/or mandibular molars with bilateral grade II furcation involvement, located on the buccal, mesial, or distal surfaces of the maxilla or mandible; or the presence of an intrabony defect; a probing depth greater than or equal to five millimeters and a horizontal probing depth greater than or equal to three millimeters (for furcation lesions) after non-surgical periodontal therapy; intraoral periapical radiographs showing radiolucency between the roots for grade II furcation defects and at least three millimeters of evident bone loss on periapical radiographs for intrabony defects; with no endodontic involvement or with satisfactory endodontic treatment

Exclusion criteria

Exclusion criteria: Medical disorders that required antibiotic prophylaxis or that could influence the response to treatment; having received periodontal treatment in the last 6 months; having used medications that affect periodontal tissues in the last 6 months; smokers or ex-smokers for less than 12 months; pregnancy; extensive prosthetic rehabilitation; undergoing orthodontic treatment; carriers of blood diseases; alcoholism and use of illicit drugs

Design outcomes

Primary

MeasureTime frame
Improvements are expected in periodontal clinical parameters assessed using a millimeter periodontal probe. Data collected before the intervention and after 45 and 90 days

Secondary

MeasureTime frame
Assessment of interproximal bone loss by periapical radiographs (baseline and 90 days);Immunological analyses will be performed before the intervention and after 45 and 90 days by ELISA to assess the protein levels of IL-1, TNF, and TGF-ß.;Assessment of periodontopathogen levels by RT-qPCR (baseline, 45 and 90 days)

Countries

Brazil

Contacts

Public ContactJovânia;Suzane Oliveira;Pigossi

Faculdade de Odontologia da Universidade Federal de Uberlândia;Faculdade de Odontologia da Universidade Federal de Uberlândia

jovania.oliveira@ufu.br;suzane.pigossi@ufu.br+55(35)98841-7537;+55(19)98141-4158

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 7, 2026