Clinical trial NCT06604013: Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System of Periodontitis
Official title: Class III Obesity and Periodontitis: Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System and Effects of Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal Diseases
Obesity, Morbid
Keywords: resistin, adiponectin, periodontitis Grading, periodontal therapy
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using ELISA in obese individuals. Researchers will compare different stages of periodontitis to see if degrees of inflammation and periodontal therapy related obesity


Eligibility criteria: Inclusion Criteria:

* obese persons with Body Mass Index (BMI) more than 40 and suffering from periodontitis

Exclusion Criteria:

* Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
* Patients subjected to previous periodontal therapy 6 months before sampling. Patients with systemic or local inflammatory conditions other than periodontal disease.
* Neither lactating nor pregnant.

Primary outcomes:
measure: adiponectin level in gingival crevicular fluid
timeFrame: From enrollment to the end of treatment results assessment at 12 weeks
measure: resistin level in gingival crevicular fluid
timeFrame: From enrollment to the end of treatment results assessment at 12 weeks
Secondary outcomes:
measure: O'Leary Plaque score
timeFrame: From enrollment to the end of treatment results assessment at 12 weeks
measure: bleeding on probing percentage (BoP)
timeFrame: From enrollment to the end of treatment results assessment at 12 weeks
measure: clinical attachment level (CAL)
timeFrame: From enrollment to the end of treatment results assessment at 12 weeks
measure: probing pocket depth
timeFrame: From enrollment to the end of treatment results assessment at 12 weeks
Other outcomes:
measure: Body Mass Index (BMI)
timeFrame: From enrollment time only
measure: glycated hemoglobin (HbA1c)
timeFrame: From enrollment time only
Locations:
city: Assiut
country: Egypt
facility: Faculty of Dental Medicine, Al-Azhar University Assiut Branch
state: Asyut
Study officials:
affiliation: Faculty of dental medicine Al-Azhar university Assiut Branch
name: Bahaa Mohammed Badr, associate professor
role: STUDY_DIRECTOR
affiliation: Faculty of dental medicine Al-Azhar university Assiut Branch
name: Asem Mohammed kamel, lecturer
role: STUDY_DIRECTOR
References:
citation: Kusminski CM, McTernan PG, Kumar S. Role of resistin in obesity, insulin resistance and Type II diabetes. Clin Sci (Lond). 2005 Sep;109(3):243-56. doi: 10.1042/CS20050078.
citation: Filkova M, Haluzik M, Gay S, Senolt L. The role of resistin as a regulator of inflammation: Implications for various human pathologies. Clin Immunol. 2009 Nov;133(2):157-70. doi: 10.1016/j.clim.2009.07.013. Epub 2009 Sep 8.
citation: Cugini MA, Haffajee AD, Smith C, Kent RL Jr, Socransky SS. The effect of scaling and root planing on the clinical and microbiological parameters of periodontal diseases: 12-month results. J Clin Periodontol. 2000 Jan;27(1):30-6. doi: 10.1034/j.1600-051x.2000.027001030.x.