Clinical trial NCT03923829: The Effect of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients
Official title: The Effect of Systemic Administration of Zinc on the Gingival Crevicular Fluid Level of Total Oxidant Capacity in Type 2 Diabetic Patients With Stage II and III Periodontitis After Non-surgical Periodontal Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Periodontitis
Keywords: zinc
Non-surgical Periodontal Therapy
stage II periodontitis
stage III periodontitis
gingival crevicular fluid
total oxidant capacity
Type 2 diabetic patients
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-04-23
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of systemic administration of zinc on the gingival crevicular fluid level of total oxidant capacity in controlled Type-2 diabetic patients with stage-II and III periodontitis after non-surgical periodontal therapy.

Detailed description: Hypozincaemia and hyperzincuria is known to be present in patients with type-2 diabetes, and Zinc supplementation is known to be helpful in restoring plasma Zinc levels to normal,Zinc's deficiency can lead to an increase in circulating glucose due to beta cells malfunctioning and resistance to insulin, which makes it easier for type 2 diabetes mellitus (DM2) to happen ,Zinc was found to be a structural part of key anti-oxidant enzymes such as superoxide dismutase (SOD), and Zinc deficiency impaired their synthesis, leading to increased oxidative stress

Eligibility criteria: Inclusion Criteria:

* Controlled Type-2 diabetes mellitus
* Stage-II \&III periodontitis
* At least 2 sites with clinical attachment loss 3 or 4 mm to ≥5 mm and radiographic bone loss 15% Extending to mid-third of root and beyond.
* Probing depth from ≤5 mm to ≥6 mm

Exclusion Criteria:

* Any periodontal or Antibiotic treatment during the last six months.
* Receiving trace element supplements in the previous three months
* Pregnant or lactating females
* Gastric or diuretic treatment
* Acute renal failure
* smoking

Primary outcomes:
measure: change from baseline Hb-A1c
timeFrame: change from baseline Hb-A1c at 3 monthes
Secondary outcomes:
measure: Hb-A1c
timeFrame: at the baseline and after 3 months
measure: Probing pocket depth
timeFrame: at the baseline and after 3 months
measure: Clinical attachment level
timeFrame: at the baseline and after 3 months
measure: Gingival index
timeFrame: at the baseline and after 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Dr. Enji Ahmed, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Dr. weam elbattawy, Lecturer
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Dr. Ollfat Shaker, professor
role: STUDY_DIRECTOR
References:
citation: Khan MI, Siddique KU, Ashfaq F, Ali W, Reddy HD, Mishra A. Effect of high-dose zinc supplementation with oral hypoglycemic agents on glycemic control and inflammation in type-2 diabetic nephropathy patients. J Nat Sci Biol Med. 2013 Jul;4(2):336-40. doi: 10.4103/0976-9668.117002.
citation: Thomas B, Prasad RB, Shetty S, Vishakh R. Comparative Evaluation of the Lipid Profile in the Serum of Patients with Type II Diabetes Mellitus and Healthy Individuals with Periodontitis. Contemp Clin Dent. 2017 Jan-Mar;8(1):96-101. doi: 10.4103/ccd.ccd_1160_16.