Effect of Non-surgical Periodontal Therapy on Gingival Crevicular Fluid Interleukin-21 Levels - Study Results

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Treatment
Conditions	Chronic Peridontitis Patients Chronic Gingivitis Healthy
Intervention	Procedure: non surgical periodontal therapy
Enrollment	34

Participant Flow

Recruitment Details	Thirty four patients (19 males and 15 females, aged 20-60 years) were consecutively enrolled over a six month period (April 2014 to September 2014) from the outpatient department of periodontology, Krishnadevaraya College of Dental Sciences, Bangalore, and Karnataka.
Pre-assignment Details	12 chronic gingivitis, 12 chronic periodontitis patients and 10 healthy individuals were included as control. Patients systemically healthy having more than or equal to 14 functional teeth, patients had not received any form of surgical/non surgical periodontal therapy or received antibiotics within the past 6 months.


Arm/Group Title	Group I (Control Group): Healthy	Group II (Test Group I): Chronic Gingivitis	Group III (Test Group II): Chronic Periodontitis
Arm/Group Description	Ten patients with clinically health...	Twelve chronic gingivitis patients ...	Twelve chronic periodontitis patien...
Arm/Group Description	Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.	Twelve chronic gingivitis patients having probing depth less than or equal to 4mm and Relative Attachment Level (RAL) less than or equal to 3mm, with more than 25% of sites with gingival bleeding present.	Twelve chronic periodontitis patients having probing depth more than or equal to 5mm and Relative Attachment Level of more than or equal to 8mm with more than 10% of sites with gingival bleeding on probing present with radiographic evidence of bone loss.
Period Title: Overall Study
Started	10	12	12
Completed	10	12	12
Not Completed	0	0	0

Baseline Characteristics

Arm/Group Title		Group I (Control Group): Healthy	Group II (Test Group I): Chronic Gingivitis	Group III (Test Group II): Chronic Periodontitis	Total
Arm/Group Description		Ten patients with clinically health...	Chronic gingivitis was defined as h...	Chronic periodontitis was defined a...	Total of all reporting groups
Arm/Group Description		Ten patients with clinically healthy gingiva with probing depth less than 3mm and less than or equal to 10% sites with gingival bleeding on probing present.	Chronic gingivitis was defined as having probing depth (PD) less than or equal to 4mm, relative attachment loss (RAL) ) less than or equal to 3mm and more than to 25% sites with gingival bleeding present (BOP) Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.	Chronic periodontitis was defined as having probing depth more than or equal to 5mm, RAL more than or equal to 8mm, with more than or equal to 10% sites with BOP positive and evidence of bone loss determined radiographically. Non surgical periodontal therapy (SRP) was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy non surgical periodontal therapy: and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.	Total of all reporting groups
Overall Number of Baseline Participants		10	12	12	34
Baseline Analysis Population Description		...
Baseline Analysis Population Description		A total of 34 patients with 19 males and 15 females in the age group of 20-60 years were included. Patients were divided into 3 groups to collect Gingival Crevicular Fluid (GCF) samples for the study.
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	10 participants	12 participants	12 participants	34 participants
		30 (0.465)	25 (0.359)	44 (0.981)	33 (7.73)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	10 participants	12 participants	12 participants	34 participants
	Female	5 50.0%	6 50.0%	4 33.3%	15 44.1%
	Male	5 50.0%	6 50.0%	8 66.7%	19 55.9%
Race and Ethnicity Not Collected ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	0 participants	0 participants	0 participants	0 participants
					0
		[1] Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment Measure Type: Count of Participants Unit of measure: Participants
India	Number Analyzed	10 participants	12 participants	12 participants	34 participants
India		10 100.0%	12 100.0%	12 100.0%	34 100.0%

Outcome Measures

1.Primary Outcome


Title	Pocket Depth
Description	Probing pocket depth (PPD) was recorded using University of North Caro...
Description	Probing pocket depth (PPD) was recorded using University of North Carolina {UNC}-15 Periodontal probe and customized occlusal stent. Pocket depth was recorded from the crest of the gingival margin to the base of the pocket. The deepest probing pocket depth in the patient"s mouth was considered.
Time Frame	6 weeks

Outcome Measure Data