Mechanisms and Treatment Response of Aggressive Periodontitis in Children

NCT01330719 | Completed

• 2 other identifiers: IRB201400349-NR01DE019456
• Study Type: interventional
• Target: 514
• Locations: 1 country
• Sites: 10

Brief Summary

Although of low prevalence, aggressive periodontitis is a rapid destructive form of periodontal disease that initiates at a young age, leading to premature loss of first molars and incisors. Little is known on the mechanisms of this disease. It is imperative to understand mechanisms of disease to establish proper treatment. We have established a controlled study in a comparable population presenting similar aggressive disease characteristics to evaluate the mechanisms of this disease. It is the goal of this study to determine immunological and microbiological mechanisms responsible for the rapid tissue destruction in children with localized aggressive periodontitis and how traditional periodontal intervention affects these mechanisms. Important knowledge gained with this proposal will aid in defining specific treatment approaches to better control disease progression and prevent disease initiation in susceptible individuals.

Conditions

Aggressive Periodontitis

Keywords

Periodontitis

Outcome Measures

Primary Outcomes (1)

• SNPs and DNA methylation

  The investigators are doing analysis of single nucleotide polymorphisms (DNA sequence variation) and methylation (addition of a methyl group) of DNA of specific genes related to inflammation.

  24 months

Secondary Outcomes (1)

• Systemic inflammatory levels

  24 months

Study Arms (2)

Diseased periodontal treatment

EXPERIMENTAL

Scaling and root planing along with systemic antibiotics (Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days).

Procedure: Diseased periodontal treatment

Conventional periodontal treatment

ACTIVE COMPARATOR

Standard periodontal prophylaxis

Procedure: Conventional periodontal treatment

Interventions

Diseased periodontal treatment PROCEDURE

Treatment includes scaling and root planing with systemic antibiotics, Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days. At certain intervals after the scaling and root planing, your gums will be reevaluated. You will receive further surgical gum therapy only if your gums haven't shown improvement after first treatment on the reevaluation appointments. If surgery is needed, a bone substituting material may be necessary to "fill" the spaces where bone has been destroyed by the disease. Extraction of teeth might also be part of gum treatment if the disease is very severe. Re-treatment with antibiotics also may be necessary depending on the response after treatment. You are usually re-examined and receive additional cleanings every 3 to 6 months to ensure the disease does not come back.

Diseased periodontal treatment

Conventional periodontal treatment PROCEDURE

Scaling and gum measurement will be taken to compare to the treated group.- If it is determined that you do not have this disease, a conventional cleaning is done, usually every 6 months. This is all part of normal clinical care.

Conventional periodontal treatment

Eligibility Criteria

• Age: 5 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

Inclusion child/adolescent: * Male or female, aged 5 to 25 * In good general health as evidenced by medical history * Diagnosed with localized aggressive periodontitis (LAP), defined by the presence of attachment loss ≥ 2mm and detected bone loss on at least two sites, involving first molars and/or incisors, or * Periodontally healthy (defined by absence of clinical signs of periodontitis) related or not to LAP participants Inclusion parent /grandparent: * Male or female, up to age 90 years * Parent or grandparent of an enrolled participant with LAP Exclusion child/adolescent: * Diagnosed with any systemic diseases or conditions that could influence the progression and/or clinical characteristics of periodontal disease (i.e., immunosuppression, diabetes, neutropenia or blood disorders). * Patients that have taken antibiotics within the last 3 months\* or require antibiotic prophylaxis prior to initial visit. * Patients that are currently taking medications that could influence the characteristics or response to periodontal treatment (example: immune-suppressive drugs, such as cyclosporine or steroids). * Smokers (≥10 cigarettes a day for over 6 months) * Pregnant/lactating women as pregnancy causes gingival changes that could confound study results. * Any psychiatric conditions that will inhibit participants from proper understanding of study procedures as determined by the PI/clinician investigator. * Patients may still enroll but will be scheduled for initial visit 3 months later Exclusion parent/grandparent: * Patients that have taken antibiotics within the last 3 months\* or require antibiotic prophylaxis prior to initial visit. * Pregnant/lactating women as pregnancy causes gingival changes that could confound study results. * Any psychiatric conditions that will inhibit participants from proper understanding of study procedures as determined by the PI/clinician investigator.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Florida: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (10)

Acorn Dental Clinic

Brooker, Florida, 32622, United States

Location

Broward College

Fort Lauderdale, Florida, 33301, United States

Location

Dental Clinical Research Unit, University of Florida

Gainesville, Florida, 32610, United States

Location

Azalea Dental Clinic

Gainesville, Florida, 32640, United States

Location

UF Hialeah Dental Clinic

Hialeah, Florida, 33013, United States

Location

Duval County Department of Health

Jacksonville, Florida, 32206, United States

Location

UF Naples Pediatric Dental Clinic

Naples, Florida, 34113, United States

Location

Gadsden County Health Department--Quincy Dental Clinic

Quincy, Florida, 32353, United States

Location

Leon County Health Department

Tallahassee, Florida, 32310, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Related Publications (28)

• Albandar JM. Epidemiology and risk factors of periodontal diseases. Dent Clin North Am. 2005 Jul;49(3):517-32, v-vi. doi: 10.1016/j.cden.2005.03.003.

  PMID: 15978239 BACKGROUND

• Albandar JM, Tinoco EM. Global epidemiology of periodontal diseases in children and young persons. Periodontol 2000. 2002;29:153-76. doi: 10.1034/j.1600-0757.2002.290108.x. No abstract available.

  PMID: 12102707 BACKGROUND

• Albandar JM. Juvenile periodontitis--pattern of progression and relationship to clinical periodontal parameters. Community Dent Oral Epidemiol. 1993 Aug;21(4):185-9. doi: 10.1111/j.1600-0528.1993.tb00753.x.

  PMID: 8370252 BACKGROUND

• Sweeney EA, Alcoforado GA, Nyman S, Slots J. Prevalence and microbiology of localized prepubertal periodontitis. Oral Microbiol Immunol. 1987 Jun;2(2):65-70. doi: 10.1111/j.1399-302x.1987.tb00292.x.

  PMID: 10870470 BACKGROUND

• Zambon JJ, Christersson LA, Slots J. Actinobacillus actinomycetemcomitans in human periodontal disease. Prevalence in patient groups and distribution of biotypes and serotypes within families. J Periodontol. 1983 Dec;54(12):707-11. doi: 10.1902/jop.1983.54.12.707.

  PMID: 6358452 BACKGROUND

• Page RC, Baab DA. A new look at the etiology and pathogenesis of early-onset periodontitis. Cementopathia revisited. J Periodontol. 1985 Dec;56(12):748-51. doi: 10.1902/jop.1985.56.12.748.

  PMID: 3866058 BACKGROUND

• Agarwal S, Suzuki JB, Riccelli AE. Role of cytokines in the modulation of neutrophil chemotaxis in localized juvenile periodontitis. J Periodontal Res. 1994 Mar;29(2):127-37. doi: 10.1111/j.1600-0765.1994.tb01101.x.

  PMID: 8158501 BACKGROUND

• Christersson LA, Slots J, Rosling BG, Genco RJ. Microbiological and clinical effects of surgical treatment of localized juvenile periodontitis. J Clin Periodontol. 1985 Jul;12(6):465-76. doi: 10.1111/j.1600-051x.1985.tb01382.x.

  PMID: 3894435 BACKGROUND

• Shaddox L, Wiedey J, Bimstein E, Magnuson I, Clare-Salzler M, Aukhil I, Wallet SM. Hyper-responsive phenotype in localized aggressive periodontitis. J Dent Res. 2010 Feb;89(2):143-8. doi: 10.1177/0022034509353397. Epub 2009 Dec 30.

  PMID: 20042739 RESULT

• Koutouzis T, Haber D, Shaddox L, Aukhil I, Wallet SM. Autoreactivity of serum immunoglobulin to periodontal tissue components: a pilot study. J Periodontol. 2009 Apr;80(4):625-33. doi: 10.1902/jop.2009.080422.

  PMID: 19335083 RESULT

• Alfant B, Shaddox LM, Tobler J, Magnusson I, Aukhil I, Walker C. Matrix metalloproteinase levels in children with aggressive periodontitis. J Periodontol. 2008 May;79(5):819-26. doi: 10.1902/jop.2008.070513.

  PMID: 18454660 RESULT

• Shaddox LM, Wiedey J, Calderon NL, Magnusson I, Bimstein E, Bidwell JA, Zapert EF, Aukhil I, Wallet SM. Local inflammatory markers and systemic endotoxin in aggressive periodontitis. J Dent Res. 2011 Sep;90(9):1140-4. doi: 10.1177/0022034511413928. Epub 2011 Jul 5.

  PMID: 21730256 RESULT

• Shaddox LM, Huang H, Lin T, Hou W, Harrison PL, Aukhil I, Walker CB, Klepac-Ceraj V, Paster BJ. Microbiological characterization in children with aggressive periodontitis. J Dent Res. 2012 Oct;91(10):927-33. doi: 10.1177/0022034512456039. Epub 2012 Aug 3.

  PMID: 22863892 RESULT

• Beliveau D, Magnusson I, Bidwell JA, Zapert EF, Aukhil I, Wallet SM, Shaddox LM. Benefits of early systemic antibiotics in localized aggressive periodontitis: a retrospective study. J Clin Periodontol. 2012 Nov;39(11):1075-81. doi: 10.1111/jcpe.12001. Epub 2012 Aug 29.

  PMID: 22931240 RESULT

• Goncalves PF, Huang H, McAninley S, Alfant B, Harrison P, Aukhil I, Walker C, Shaddox LM. Periodontal treatment reduces matrix metalloproteinase levels in localized aggressive periodontitis. J Periodontol. 2013 Dec;84(12):1801-8. doi: 10.1902/jop.2013.130002. Epub 2013 Mar 28.

  PMID: 23537121 RESULT

• Branco-de-Almeida LS, Cruz-Almeida Y, Gonzalez-Marrero Y, Kudsi R, de Oliveira ICV, Dolia B, Huang H, Aukhil I, Harrison P, Shaddox LM. Treatment of localized aggressive periodontitis alters local host immunoinflammatory profiles: A long-term evaluation. J Clin Periodontol. 2021 Feb;48(2):237-248. doi: 10.1111/jcpe.13404. Epub 2020 Dec 16.

  PMID: 33205510 DERIVED

• Velsko IM, Harrison P, Chalmers N, Barb J, Huang H, Aukhil I, Shaddox L. Grade C molar-incisor pattern periodontitis subgingival microbial profile before and after treatment. J Oral Microbiol. 2020 Sep 13;12(1):1814674. doi: 10.1080/20002297.2020.1814674.

  PMID: 33062199 DERIVED

• Harris TH, Wallace MR, Huang H, Li H, Shaddox LM. Associations of P2RX7 Functional Diplotypes with Localized Aggressive Periodontitis. JDR Clin Trans Res. 2019 Oct;4(4):342-351. doi: 10.1177/2380084419863789. Epub 2019 Jul 18.

  PMID: 31319038 DERIVED

• Shaddox LM, Mullersman AF, Huang H, Wallet SM, Langaee T, Aukhil I. Epigenetic regulation of inflammation in localized aggressive periodontitis. Clin Epigenetics. 2017 Sep 2;9:94. doi: 10.1186/s13148-017-0385-8. eCollection 2017.

  PMID: 28883894 DERIVED

• Branco-de-Almeida LS, Cruz-Almeida Y, Gonzalez-Marrero Y, Huang H, Aukhil I, Harrison P, Wallet SM, Shaddox LM. Local and Plasma Biomarker Profiles in Localized Aggressive Periodontitis. JDR Clin Trans Res. 2017 Jul;2(3):258-268. doi: 10.1177/2380084417701898. Epub 2017 Apr 14.

  PMID: 28879248 DERIVED

• Burgess D, Huang H, Harrison P, Aukhil I, Shaddox L. Aggregatibacter actinomycetemcomitans in African Americans with Localized Aggressive Periodontitis. JDR Clin Trans Res. 2017 Jul;2(3):249-257. doi: 10.1177/2380084417695543. Epub 2017 Mar 1.

  PMID: 28879247 DERIVED

• Burgess DK, Huang H, Harrison P, Kompotiati T, Aukhil I, Shaddox LM. Non-Surgical Therapy Reduces Presence of JP2 Clone in Localized Aggressive Periodontitis. J Periodontol. 2017 Dec;88(12):1263-1270. doi: 10.1902/jop.2017.170285. Epub 2017 Aug 18.

  PMID: 28820321 DERIVED

• Miller KA, Branco-de-Almeida LS, Wolf S, Hovencamp N, Treloar T, Harrison P, Aukhil I, Gong Y, Shaddox LM. Long-term clinical response to treatment and maintenance of localized aggressive periodontitis: a cohort study. J Clin Periodontol. 2017 Feb;44(2):158-168. doi: 10.1111/jcpe.12640. Epub 2016 Dec 27.

  PMID: 27767222 DERIVED

• Shaddox LM, Spencer WP, Velsko IM, Al-Kassab H, Huang H, Calderon N, Aukhil I, Wallet SM. Localized aggressive periodontitis immune response to healthy and diseased subgingival plaque. J Clin Periodontol. 2016 Sep;43(9):746-53. doi: 10.1111/jcpe.12560. Epub 2016 Jul 15.

  PMID: 27037664 DERIVED

• Allin N, Cruz-Almeida Y, Velsko I, Vovk A, Hovemcamp N, Harrison P, Huang H, Aukhil I, Wallet SM, Shaddox LM. Inflammatory Response Influences Treatment of Localized Aggressive Periodontitis. J Dent Res. 2016 Jun;95(6):635-41. doi: 10.1177/0022034516631973. Epub 2016 Feb 25.

  PMID: 26917438 DERIVED

• Merchant SN, Vovk A, Kalash D, Hovencamp N, Aukhil I, Harrison P, Zapert E, Bidwell J, Varnado P, Shaddox LM. Localized aggressive periodontitis treatment response in primary and permanent dentitions. J Periodontol. 2014 Dec;85(12):1722-9. doi: 10.1902/jop.2014.140171.

  PMID: 25186780 DERIVED

• Goncalves PF, Klepac-Ceraj V, Huang H, Paster BJ, Aukhil I, Wallet SM, Shaddox LM. Correlation of Aggregatibacter actinomycetemcomitans detection with clinical/immunoinflammatory profile of localized aggressive periodontitis using a 16S rRNA microarray method: a cross-sectional study. PLoS One. 2013 Dec 23;8(12):e85066. doi: 10.1371/journal.pone.0085066. eCollection 2013.

  PMID: 24376864 DERIVED

• Shaddox LM, Goncalves PF, Vovk A, Allin N, Huang H, Hou W, Aukhil I, Wallet SM. LPS-induced inflammatory response after therapy of aggressive periodontitis. J Dent Res. 2013 Aug;92(8):702-8. doi: 10.1177/0022034513495242. Epub 2013 Jun 20.

  PMID: 23788609 DERIVED

MeSH Terms

Conditions

Aggressive Periodontitis; Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Ikramuddin Aukhil

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 7, 2011
• Study Start: December 1, 2006
• Primary Completion: May 29, 2019
• Study Completion: December 2, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)