Periodontitis and Adverse Pregnancy Outcomes in Metabolic Syndrome Patients- Interventional Study

NCT03381469 | Unknown

• 1 other identifier: MetS in Pregnancy
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

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

1. 1.To evaluate the changes in periodontal status of pregnant women with metabolic syndrome after non surgical periodontal therapy (NSPT)
2. 2.To evaluate the inflammatory marker levels in serum of pregnant women with metabolic syndrome after non surgical periodontal therapy
3. 3.To evaluate the effect of NSPT on adverse pregnancy outcomes of women with metabolic syndrome

Conditions

Low Birth Weight Baby; Metabolic Syndrome; Pregnancy Complications; Adverse Pregnancy Outcomes; Periodontitis; Premature Birth

Outcome Measures

Primary Outcomes (5)

• 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

  • 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

  • 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

  • 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

  • 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

  • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery

Secondary Outcomes (4)

• Serum bio markers -Change in Interleukin-6(IL-6)

  • 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)

  • At baseline (before 20 weeks gestation) • 8 weeks after completion of periodontal therapy • Within 1-2 days of delivery

• Pregnancy Outcomes -Preterm birth neonate

  • Within 1-2 days of delivery

• Pregnancy Outcomes -Low birth weight neonate

  • Within 1-2 days of delivery

Study Arms (3)

Periodontitis patients undergoing NSPT

EXPERIMENTAL

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

Periodontitis Patients undergoing supragingival scaling

ACTIVE COMPARATOR

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

Without Periodontitis undergoing supragingival scaling

ACTIVE COMPARATOR

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

Interventions

Comprehensive periodontal treatment PROCEDURE

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)

Periodontitis patients undergoing NSPT

single visit supragingival scaling PROCEDURE

The control and Placebo group participants will receive oral hygiene instruction and supragingival cleaning of all teeth at their baseline visit.

Periodontitis Patients undergoing supragingival scaling; Without Periodontitis undergoing supragingival scaling

Eligibility Criteria

• Age: 18 Years - 34 Years
• Gender Eligibility Details: Female only
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with Mets
• Primi gravida
• Singleton pregnancy \< 20 weeks gestation
• years of age
• More than 20 teeth in the mouth

You may not qualify if:

• Previous history of abortion
• Assisted reproduction procedures like fertility medication or in vitro fertilization
• Positive history of HIV
• Positive history of genitourinary infections in previous 6 months
• Any medical contraindication to periodontal probing
• Undergone periodontal treatment or using chlorhexidine or other mouth rinses in the previous 6 months
• Rampant decay
• Taken systemic antibiotic or anti-inflammatory drugs in the last 6 months before the start of the study, or reported use of phenytoin, cyclosporine, calcium antagonists and/or hormone replacement therapy
• Alcoholics
• Smokers and ex-smokers
• History of kidney, liver or lung disease
• History of any other chronic or acute infections during the previous 6 months as assessed on clinical examination or routine lab testing

Sponsors & Collaborators

• Riyadh Colleges of Dentistry and Pharmacy: lead

Study Sites (2)

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, 11681, Saudi Arabia

RECRUITING

Riyadh Colleges of Dentistry and Pharmacy

Riyadh, 11681, Saudi Arabia

RECRUITING

Related Publications (20)

• Al-Nozha M, Al-Khadra A, Arafah MR, Al-Maatouq MA, Khalil MZ, Khan NB, Al-Mazrou YY, Al-Marzouki K, Al-Harthi SS, Abdullah M, Al-Shahid MS, Al-Mobeireek A, Nouh MS. Metabolic syndrome in Saudi Arabia. Saudi Med J. 2005 Dec;26(12):1918-25.

  PMID: 16380773 BACKGROUND

• Al Qahtani NA, Joseph B, Deepthi A, Vijayakumari BK. Prevalence of chronic periodontitis and its risk determinants among female patients in the Aseer Region of KSA. J Taibah Univ Med Sci. 2017 Mar 3;12(3):241-248. doi: 10.1016/j.jtumed.2016.11.012. eCollection 2017 Jun.

  PMID: 31435246 BACKGROUND

• Al-Qurashi FO, Yousef AA, Awary BH. Epidemiological aspects of prematurity in the Eastern region of Saudi Arabia. Saudi Med J. 2016 Apr;37(4):414-9. doi: 10.15537/smj.2016.4.14309.

  PMID: 27052284 BACKGROUND

• Athyros VG, Ganotakis ES, Elisaf M, Mikhailidis DP. The prevalence of the metabolic syndrome using the National Cholesterol Educational Program and International Diabetes Federation definitions. Curr Med Res Opin. 2005 Aug;21(8):1157-9. doi: 10.1185/030079905x53333.

  PMID: 16083523 BACKGROUND

• Benguigui C, Bongard V, Ruidavets JB, Chamontin B, Sixou M, Ferrieres J, Amar J. Metabolic syndrome, insulin resistance, and periodontitis: a cross-sectional study in a middle-aged French population. J Clin Periodontol. 2010 Jul;37(7):601-8. doi: 10.1111/j.1600-051X.2010.01571.x. Epub 2010 May 13.

  PMID: 20492076 BACKGROUND

• Blencowe H, Cousens S, Oestergaard MZ, Chou D, Moller AB, Narwal R, Adler A, Vera Garcia C, Rohde S, Say L, Lawn JE. National, regional, and worldwide estimates of preterm birth rates in the year 2010 with time trends since 1990 for selected countries: a systematic analysis and implications. Lancet. 2012 Jun 9;379(9832):2162-72. doi: 10.1016/S0140-6736(12)60820-4.

  PMID: 22682464 BACKGROUND

• Dos Prazeres Tavares H, Dos Santos DC, Abbade JF, Negrato CA, de Campos PA, Calderon IM, Rudge MV. Prevalence of metabolic syndrome in non-diabetic, pregnant Angolan women according to four diagnostic criteria and its effects on adverse perinatal outcomes. Diabetol Metab Syndr. 2016 Mar 22;8:27. doi: 10.1186/s13098-016-0139-3. eCollection 2016.

  PMID: 27006707 BACKGROUND

• Green SB. How Many Subjects Does It Take To Do A Regression Analysis. Multivariate Behav Res. 1991 Jul 1;26(3):499-510. doi: 10.1207/s15327906mbr2603_7.

  PMID: 26776715 BACKGROUND

• Ide M, Papapanou PN. Epidemiology of association between maternal periodontal disease and adverse pregnancy outcomes--systematic review. J Clin Periodontol. 2013 Apr;40 Suppl 14:S181-94. doi: 10.1111/jcpe.12063.

  PMID: 23627328 BACKGROUND

• Iheozor-Ejiofor Z, Middleton P, Esposito M, Glenny AM. Treating periodontal disease for preventing adverse birth outcomes in pregnant women. Cochrane Database Syst Rev. 2017 Jun 12;6(6):CD005297. doi: 10.1002/14651858.CD005297.pub3.

  PMID: 28605006 BACKGROUND

• International Diabetes Federation. Information on the IDF consensus worldwide definition of the metabolic syndrome. http://www.idf.org/webdata/docs/IDF_Meta_def_final.pdf Accessed 2014 Apr 10.

  BACKGROUND

• Knight ET, Liu J, Seymour GJ, Faggion CM Jr, Cullinan MP. Risk factors that may modify the innate and adaptive immune responses in periodontal diseases. Periodontol 2000. 2016 Jun;71(1):22-51. doi: 10.1111/prd.12110.

  PMID: 27045429 BACKGROUND

• Fiorini T, Susin C, da Rocha JM, Weidlich P, Vianna P, Moreira CH, Bogo Chies JA, Rosing CK, Oppermann RV. Effect of nonsurgical periodontal therapy on serum and gingival crevicular fluid cytokine levels during pregnancy and postpartum. J Periodontal Res. 2013 Feb;48(1):126-33. doi: 10.1111/j.1600-0765.2012.01513.x. Epub 2012 Jul 27.

  PMID: 22835005 BACKGROUND

• Grundy SM. Metabolic syndrome pandemic. Arterioscler Thromb Vasc Biol. 2008 Apr;28(4):629-36. doi: 10.1161/ATVBAHA.107.151092. Epub 2008 Jan 3.

  PMID: 18174459 BACKGROUND

• LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.

  PMID: 14121956 BACKGROUND

• Offenbacher S, Beck JD, Jared HL, Mauriello SM, Mendoza LC, Couper DJ, Stewart DD, Murtha AP, Cochran DL, Dudley DJ, Reddy MS, Geurs NC, Hauth JC; Maternal Oral Therapy to Reduce Obstetric Risk (MOTOR) Investigators. Effects of periodontal therapy on rate of preterm delivery: a randomized controlled trial. Obstet Gynecol. 2009 Sep;114(3):551-559. doi: 10.1097/AOG.0b013e3181b1341f.

  PMID: 19701034 BACKGROUND

• Page RC, Eke PI. Case definitions for use in population-based surveillance of periodontitis. J Periodontol. 2007 Jul;78(7 Suppl):1387-99. doi: 10.1902/jop.2007.060264.

  PMID: 17608611 BACKGROUND

• Penova-Veselinovic B, Keelan JA, Wang CA, Newnham JP, Pennell CE. Changes in inflammatory mediators in gingival crevicular fluid following periodontal disease treatment in pregnancy: relationship to adverse pregnancy outcome. J Reprod Immunol. 2015 Nov;112:1-10. doi: 10.1016/j.jri.2015.05.002. Epub 2015 May 27.

  PMID: 26093363 BACKGROUND

• Sanz M, D'Aiuto F, Deanfield J, Fernandez-Avilés F. European workshop in periodontal health and cardiovascular disease-scientific evidence on the association between periodontal and cardiovascular diseases: A review of the literature. Eur Heart J Suppl 2010;12 Suppl B:B3-12

  BACKGROUND

• SILNESS J, LOE H. PERIODONTAL DISEASE IN PREGNANCY. II. CORRELATION BETWEEN ORAL HYGIENE AND PERIODONTAL CONDTION. Acta Odontol Scand. 1964 Feb;22:121-35. doi: 10.3109/00016356408993968. No abstract available.

  PMID: 14158464 BACKGROUND

MeSH Terms

Conditions

Metabolic Syndrome; Pregnancy Complications; Periodontitis; Premature Birth

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Obstetric Labor, Premature; Obstetric Labor Complications

Study Officials

• Hezekiah Mosadomi, DMD

  Riyadh Colleges of Dentistry and Pharmacy

  STUDY CHAIR

Central Study Contacts

Ghousia Sayeed, MDS

CONTACT

00955509731023; dr_ghousia@riyadh.edu.sa

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Three groups of patients will be examined parallel to each other

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 22, 2017
• Study Start: February 10, 2018
• Primary Completion: August 1, 2018
• Study Completion: December 1, 2018
• Last Updated: February 13, 2018

Record last verified: 2018-02

Locations

SA (2)