An interventional study of Comprehensive periodontal treatment and single visit supragingival scaling in Low Birth Weight Baby, Metabolic Syndrome and Pregnancy Complications, sponsored by Riyadh Colleges of Dentistry and Pharmacy. Status unknown at 2 sites in Saudi Arabia. Open to female participants aged 18 Years to 34 Years. Per ClinicalTrials.gov, last updated 2018-02-13.
Sponsored by Riyadh Colleges of Dentistry and Pharmacy · Not applicable, Interventional, and Diagnostic
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Aim The Aim of the current study is to establish the association between periodontitis and adverse pregnancy outcomes in metabolic syndrome (Mets) patients and to evaluate the effect of intervention.
Objectives
Research Design/Methodology Ethics approval will be obtained from Institution Review Board of Riyadh Colleges of Dentistry and Pharmacy.
Sample size calculation (Green, 1991) By considering the Green's formula as below; Medium effect size (R2=0.07) variance in dependent variable accounted for by the independent variable. Beta weights of (ß=0.20). N≥104+k (Number of independent variable) .Hence total sample size required by considering 8 independent variables will be N=104+8=112. Expecting a patient drop out rate of 30%, the sample size is being increased to 50 patients per group. Approximately 150 patients will be recruited from maternity hospitals of Riyadh City.
Written informed consent will be obtained from patients after explaining the details of the study. Patients will be evaluated using a detailed questionnaire. Demographic characteristics such as age, diet, medical history etc will be recorded. All participants will be interviewed by principal investigator at each visit to capture oral hygiene knowledge and behaviors and exposure to risk factors for adverse pregnancy outcomes. Reviews of medical records will be conducted by principal investigator to record pregnancy history, document the course of the current pregnancy, and record any adverse events. All patients will be advised to report immediately to our dental clinic in case they have any dental related issues during the study period.
Examination Procedure All dental examinations will be performed by principal investigator. Clinical oral examinations will record number of teeth, the number of filled and carious teeth.
Outcome Measures: Periodontal parameters: Gingival Index, Plaque Index, Bleeding on probing, Probing depth (PD), Clinical attachment loss (CAL)
A complete periodontal examination will be conducted with the following assessments:
Bleeding on probing, Probing depth and clinical attachment level will be evaluated at six sites per tooth, whereas plaque index and gingival index will be evaluated at four sites per tooth.
Gingival index (GI). All teeth except third molars will be evaluated for gingival inflammation using a modification of the Loe and Silness , 1963 GI. The GI uses the following scores: 0 = normal gingiva; 1 = mild inflammation; 2 = moderate inflammation; and 3 = severe inflammation.
Plaque index (PI). Prebrushing plaque scores for the buccal surface of each tooth will be assigned using a zero to three scale (Silness and Loe, 1964 ) PI, with ''0''indicating an absence of plaque on the clinical crown and a ''3'' indicating the presence of soft deposits covering more than two-thirds of the crown.
Bleeding on probing (BOP). BOP will be assessed during and recorded after probing measures will be taken for each quadrant. The scoring will be as follows:
0 = absence of bleeding; 1 = bleeding present.
Probing depth. and gingival recession .A manual periodontal probe University of North Carolina -15 probe (UNC-15) , Hu-Friedy, Chicago, Illinois ,will be used to record on all teeth present in the mouth.
Probing depth will be calculated from gingival margin to base of pocket. CAL will be calculated using the clinically detectable cemento-enamel junction (CEJ) as reference and it will be measured from CEJ to base of pocket.
Case definition of Periodontitis outlined by Page \& Eke (2007) will be used. The case definition for severe periodontitis requires two or more interproximal sites with CAL > 6 mm, not on the same tooth, and one or more interproximal sites with PD >5 mm. Moderate periodontitis is defined as two or more interproximal sites with CAL >4 mm, not on the same tooth, or two or more interproximal sites with PD >5 mm, not on the same tooth.
Adult Treatment Panel (ATP) III criteria for Mets will be met if an individual has three or more of the following components (Dos Prazeres Tavares et al, 2016):
Abdominal obesity: waist circumference >88 cm (35 inches) in women; Pregestation Body mass index (BMI) > 30kg/m2 High fasting glucose (FPG): serum glucose level > 110 mg/dl (6.1 mmol/l) or on treatment for diabetes; High blood pressure (BP): systolic BP >130 mm Hg and/or diastolic BP >85 mm Hg or on treatment for hypertension (HTN) Hypertriglyceridemia: serum triglyceride level >150 mg/dl (1.69 mmol/l); and Low high-density lipoprotein (HDL) cholesterol: Serum HDL cholesterol \<50 mg/dl (1.29 mmol/l) in women.
Clinical data and samples of blood will be collected at three intervals
Serum bio markers: Interleukin-6(IL-6), Prostaglandin-E2 (PG-E2)
Pregnancy Outcomes: Preterm birth \< 37 weeks, Low birth weight \< 2500 gms, Preterm low birth weight.
The patients and technicians who will perform the lab analyses will be blinded to group assignment.
Study Design It is a randomized clinical trial. Group 1- Case- Periodontitis patients undergoing Comprehensive periodontal treatment Group 2- Control- Periodontitis Patients undergoing single visit supragingival scaling Group 3- Placebo- Patients without Periodontitis undergoing single visit supragingival scaling After the collection of clinical data, the participants will be randomly allocated to either groups of the study using sealed opaque envelopes labeled with a study number and containing the group allocation. Allocations will be computer generated by a third person who will not otherwise be involved in the study. The Case group participants will receive non-surgical periodontal therapy that will be completed by the end of week 20-21 of gestation. This will consist of oral hygiene instruction with comprehensive periodontal treatment which will include excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth followed by supragingival and subgingival scaling and root planing (SRP) of sites with PDs > 4 mm and polishing of all the teeth. Participants will be offered treatment under local anesthetic when necessary. No limits will be imposed on the number of dental visits needed to accomplish periodontal therapy.
The control and Placebo group participants will receive oral hygiene instruction and supragingival cleaning of all teeth at their baseline visit. Clinical periodontal related data will be collected at a subsequent review appointment 8 weeks after treatment for all groups.
All control participants will be offered the opportunity to attend for comprehensive periodontal therapy postpartum.
Blood samples will be collected after 10 hours of over night fasting. Serum triglyceride, Serum HDL cholesterol and serum glucose will be quantified using standard laboratory procedures in same medical laboratory for all samples collected.
A 5-ml sample of peripheral venous blood will be collected by vein puncture. The blood samples will be centrifuged at 3000 g for 5 min and the serum will be separated. The serum samples will be frozen in plastic vials at -20º Centigrade until further analyzing. Commercially available ELISA assays will be used to measure concentrations of IL-6, and PGE2 in blood samples, according to the manufacturer's recommendations.
Data analysis will be done using Statistical Package for the Social Sciences (SPSS) software. Mean and standard deviation for all clinical parameters. Differences between groups will be assessed using independent t-tests. Sample distribution according to demographic, socio-economic and behavioral data will be assessed using chi-square and Fisher_s exact tests. Between-group differences on the distribution of obstetric data will be assessed using Fisher_s exact test, and differences in adverse pregnancy outcomes will be compared using the independent t-test. Serum bio markers will be presented as median and 25% and 75% percentiles. Differences between groups will be assessed using the Mann- Whitney U-test, and differences among experimental periods will be assessed using the Wilcoxon signed-rank test. The Holm-Bonferroni method will be used to adjust for multiple comparisons. Statistical significance will be set at 5%
2,117 studies on the registry are indexed under Metabolic Syndrome; 347 are open to participants now.
This study's planned enrollment of 150 is above the median of 60 across 1,573 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →Riyadh Colleges of Dentistry and Pharmacy is the lead sponsor of 28 studies on the registry; 1 is open to participants now.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Case group participants will receive comprehensive periodontal treatment also known as non-surgical periodontal therapy (NSPT) that will be completed by the end of week 20-21 of gestation.
Procedure: Comprehensive periodontal treatment
The control group participants with periodontitis will receive oral hygiene instruction and single visit supragingival scaling of all teeth at their baseline visit.
Procedure: single visit supragingival scaling
Placebo group participants without periodontitis will receive oral hygiene instruction and single visit supragingival scaling of all teeth at their baseline visit.
Procedure: single visit supragingival scaling
The Case group participants will receive non-surgical periodontal therapy that will be completed by the end of week 20-21 of gestation. This will consist of oral hygiene instruction with comprehensive periodontal treatment which will include excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth followed by supragingival and subgingival scaling and root planing (SRP) of sites with PDs \> 4 mm and polishing of all the teeth. Participants will be offered treatment under local anesthetic when necessary. No limits will be imposed on the number of dental visits needed to accomplish periodontal therapy.
Also known as: Non Surgical Periodontal Therapy (NSPT)
The control and Placebo group participants will receive oral hygiene instruction and supragingival cleaning of all teeth at their baseline visit.
Periodontal parameters- Change in Gingival Index
Gingival index (GI). All teeth except third molars will be evaluated for gingival inflammation using a modification of the Loe and Silness , 1963 GI. The GI uses the following scores: 0 = normal gingiva; 1 = mild inflammation; 2 = moderate inflammation; and 3 = severe inflammation. Gingival index will be evaluated at four sites per tooth
Time frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Periodontal parameters- Change in Plaque Index
Plaque index (PI). Prebrushing plaque scores for the buccal surface of each tooth will be assigned using a zero to three scale (Silness and Loe, 1964 ) PI, with ''0''indicating an absence of plaque on the clinical crown and a ''3'' indicating the presence of soft deposits covering more than two-thirds of the crown. Plaque index will be evaluated at four sites per tooth
Time frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Periodontal parameters-Change in Bleeding on probing
Bleeding on probing will be evaluated at six sites per tooth
Time frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Periodontal parameters- Change in Probing depth (PD)
A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. Probing depth will be calculated from gingival margin to base of pocket. Probing depth will be evaluated at six sites per tooth
Time frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Periodontal parameters- Change in Clinical attachment level (CAL)
A manual periodontal probe UNC-15, Hu-Friedy, Chicago, IL ,will be used to record on all teeth present in the mouth. CAL will be calculated using the clinically detectable cemento-enamel junction (CEJ) as reference and it will be measured from CEJ to base of pocket. Clinical attachment level will be evaluated at six sites per tooth
Time frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Serum bio markers -Change in Interleukin-6(IL-6)
A 5-ml sample of peripheral venous blood will be collected by vein puncture. The blood samples will be centrifuged at 3000 g for 5 min and the serum will be separated. The serum samples will be frozen in plastic vials at -20ºC until further analyzing. Commercially available ELISA assays will be used to measure concentrations of IL-6 in blood samples, according to the manufacturer's recommendations.
Time frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Serum bio markers -Change in Prostaglandin-E2 ( PG-E2)
A 5-ml sample of peripheral venous blood will be collected by vein puncture. The blood samples will be centrifuged at 3000 g for 5 min and the serum will be separated. The serum samples will be frozen in plastic vials at -20ºC until further analyzing. Commercially available ELISA assays will be used to measure concentrations of PGE2 in blood samples, according to the manufacturer's recommendations.
Time frame: • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery
Pregnancy Outcomes -Preterm birth neonate
Preterm birth \< 37 weeks neonate taken from patients record
Time frame: • Within 1-2 days of delivery
Pregnancy Outcomes -Low birth weight neonate
Low birth weight \< 2500 gms neonate as taken from patients record
Time frame: • Within 1-2 days of delivery
Plan to share: Undecided
Started Feb 2018 (actual). Primary completion is estimated for Aug 2018, 5 months after the start.
Of 625 non-industry interventional studies with no phase under Metabolic Syndrome, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 41. This study's planned 5 months is below that.
Counting every sponsor, half of 675 studies reached it within 20 months; a quarter within 9 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Riyadh Colleges of Dentistry and Pharmacy