Periodontitis
Conditions
Interventions
A parallel, double-blind, controlled and randomized clinical trial with 10 arms where the following interventions will be carried out:SRP-Group (n=20) – diabetic patients who will receive only non-sur
SRP-ATB group (n=20) – diabetic patients who will receive non-surgical periodontal treatment and antibiotic therapy
Group-SRP-PBMT (n=20) – diabetic patients who will receive non-surgical periodontal treatment and photobiomodulation.
SRP-Group (n=20) – healthy patients who will receive only non-surgical periodonta
SRP-ATB group (n=20) – healthy patients who will receive non-surgical periodontal treatment and antibiotic therapy
Group-SRP-PBMT (n=20) – healthy patients who will receive non-surgical periodontal treatment and photobiomodulation. Patients undergoing tooth extraction and bone grafting: SAU/CTR Group (n=12) - Heal
DIA/CTR Group (n=12) - Diabetic patients without PBMT treatment
SAU/PBMT Group (n=12) - Healthy patients treated with PBMT
DIA/PBMT group (n=12) - Diabetic patients treated with PBMT. All patients (n=48) will undergo rehabilitation with implants.
E02.594
D25.339.312
Sponsors
Universidade Federal de Uberlândia
Universidade Federal de Uberlândia
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Study 1: Participants will be selected according to the following inclusion criteria: 18 years old, positive diagnosis for Grade B or C periodontal disease, stages 2-4; presence of at least 16 teeth in the oral cavity, with at least 4 non-neighboring sites with a probing depth of 5 mm and bleeding, absence of periodontal treatment one year before the research and not having used antibiotics in the last three months . Study 2: During study 1, patients who consent to participate in study 2 must present the following characteristics: Individuals over 18 years of age; individuals with teeth condemned due to lack of periodontal support; individuals who are indicated for future rehabilitation with an implant (in the region of the units to be extracted); individuals with ASA I or II classification; individuals with the cognitive capacity to maintain their own oral hygiene.”
Exclusion criteria
Exclusion criteria: "Study 1: The following will be excluded from the study: pregnant or lactating women, who have periodontal treatment in less than a year, who have used antibiotics in the last three months, patients using antiresorptive medications.Study 2: The following will be excluded from this study: patients who are metabolically decompensated (ASA classification equal to or greater than III - except diabetics); chronic users of antiresorptive and immunosuppressive medications; patients who present acute periodontitis; heavy smokers (more than 10 cigarettes per day); pregnant and breastfeeding women; history of radiotherapy to the head and neck; have a diagnosis of bruxism; immunosuppressed; teeth with root dilaceration or condition that requires odontosection.”
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a gain in clinical attachment level above 1mm on average in teeth treated with the photobiomodulation group compared to patients treated in the control and antibiotic therapy groups.;It is expected 1mm less peri-implant bone loss to occur with implants placed in grafted and non-grafted areas previously treated with photobiomodulation than in areas not treated with photobiomodulation | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that 10% expression of inflammatory markers and pathogenic microbiota associated with periodontal disease will occur in the groups treated with photobiomodulation compared to the control and antibiotic therapy groups.;It is expected a 10% of reduction in bleeding on probing and probing depth in the photobiomodulation group compared to the control and antibiotic therapy groups;It is expected that the primary stability of implants installed in grafted and non-grafted areas will increase by 10 points (Implant Stability Quotient) in implants in the group treated with photobiomodulation compared to implants installed in grafted and non-grafted areas not treated with photobiomodulation;It is expected 10% more bone formation in grafted and non-grafted areas treated with photobiomodulation than grafted and non-grafted areas that were not treated with photobiomodulation in the evaluation by histomorphometric analysis | — |
Countries
Brazil
Contacts
Public ContactGuilherme Oliveira
Universidade Federal de Uberlândia
Outcome results
None listed