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Immediate Implant Placement in Aggressive Periodontitis (implant)

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ClinicalTrials.gov Identifier: NCT03218228
Recruitment Status : Unknown
Verified July 2017 by nermin mohammed ahmed yussif, Cairo University.
Recruitment status was:  Recruiting
First Posted : July 14, 2017
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
nermin mohammed ahmed yussif, Cairo University

Brief Summary:
The aim of the present study is to evaluate the health of immediately placed dental implants in aggressive periodontitis patients versus those placed in periodontally healthy individuals in the maxillary esthetic zone.

Condition or disease Intervention/treatment Phase
Periodontitis Procedure: implants in periodontitis Not Applicable

Detailed Description:

Aggressive periodontitis is an enigmatic periodontal disease that characterized by massive and undeterminable periods of tissue destruction. It gets along well to young individuals with successive periods of disease activity. Aggressive bone destruction with limited plaque and calculus deposits usually detected. According to microbial theory, Aggregatibacter actinomycetemcomitans (A.a) and P. gingivalis (P. G) were claimed for such a disease. Patients of aggressive periodontitis have disturbed esthetic and masticatory function problems.

After wards, microbial theory was modified to enroll the genetic background that can be the cause behind the developed body resistance. Although the importance of the genetic treatment to improve the body response, it was totally dismissed during the routine periodontal work attributable to high cost effectiveness of the needed genetic analysis especially in developing countries.

Further researches tried to explain the cause behind the impaired body response. Impaired functions of the immune cells and the massive amounts of catabolic cytokines such as IL-1, IL-6, Il-17, TNF- α and prostaglan¬din E2 (PGE2) are usually released during the active periods of the disease. On the other hand, matrix-metalloproteinases are destructive enzymes that released in an uncontrollable manner. Host modulators were suggested to control the released of the destructive agents.

Immediate implant placement provides an efficient modality that shortens the dental management period. The aim behind immediate implant placement is the proper implant positioning to counteract the advanced bone resorption following extraction.

Periodontitis is considered an important risk factor for peri-implantitis. The pre-existing periodontitis must be treated prior to implant placement in order to avoid the bacterial accumulation in the periodontal lesions regardless the type of periodontitis. Local and systemic supportive therapy is strongly recommended in order to reduce the microbial colonies and post-operative bone loss.

Higher rate of implant failure (peri-implantitis) has been reported in immediately placed implants when compared with the delayed conventional technique. The failure rate markedly increased with the immediate placement of implants in patients with history of periodontitis especially the aggressive form.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Health of Peri-implant Tissues Around Immediately Placed Dental Implants in Aggressive Periodontitis Patients Versus Periodontally Healthy Individuals in Maxillary Esthetic Zone
Actual Study Start Date : June 10, 2017
Estimated Primary Completion Date : August 8, 2018
Estimated Study Completion Date : December 8, 2018

Arm Intervention/treatment
Placebo Comparator: implants in healthy individuals
immediate placement of dental implants in individuals with healthy periodontium. the device is dental implants, radiographs, william's periodontal probe
Procedure: implants in periodontitis
it targets immediate implant placement in patients suffering from aggressive periodontitis
Other Name: implants in aggressive periodontitis

Experimental: implants in periodontitis patients
immediate implantation in patients suffering from aggressive periodontitis. the device is the dental implants, radiographs, william's periodontal probe
Procedure: implants in periodontitis
it targets immediate implant placement in patients suffering from aggressive periodontitis
Other Name: implants in aggressive periodontitis




Primary Outcome Measures :
  1. implant and peri-implant tissues health [ Time Frame: 12 months following implant placement ]
    it includes evaluation of the health of the placed implant in aggressive periodontitis patients and the surrounding alveolar bone and soft tissue. in other wards it evaluate the survival rate of the dental implants placed in aggressive periodontitis patients. the health condition of the placed implants are evaluated according to scale called health scale which include 5 categories in which probing depth, alveolar bone ressorption, mobility, pain and other items are measured).


Secondary Outcome Measures :
  1. midfacial peri-implant mucosal level [ Time Frame: 12 months following implant placement ]
    evaluattion of the mucosal level at the midfacial site of the immediately placed dental implants



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • Subjects aged above 18 years old.

    • Patients should be free from any systemic disease.
    • patients with good oral hygiene
    • completely or partially edenthulus patients

Exclusion Criteria:

  • Current and former smokers.

    • Pregnant females.
    • Patients with systemic diseases that may interfere with periodontal condition
    • Uncooperative patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218228


Contacts
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Contact: nermin M yussif, TA 01118271929 dr_nermin_yussif@yahoo.com
Contact: ahmed reda, T 01006608568 dr.a.reda@gmail.com

Locations
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Egypt
Octobar University of Modern Sciences and Arts Recruiting
Giza, Egypt
Contact: nermin yussif, TA    01118271929    dr_nermin_yusuf@yahoo.com   
Contact: rasha attia, TA    01009032255    periorasha1@gmail.com   
Sponsors and Collaborators
Cairo University
Investigators
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Study Director: mona darhous, Prof faculty of oral and dental medicine cairo university

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Responsible Party: nermin mohammed ahmed yussif, principal investigator-faculty of oral and dental medicine, Cairo University
ClinicalTrials.gov Identifier: NCT03218228     History of Changes
Other Study ID Numbers: immediate implant
First Posted: July 14, 2017    Key Record Dates
Last Update Posted: July 18, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by nermin mohammed ahmed yussif, Cairo University:
aggressive periodontitis

Additional relevant MeSH terms:
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Periodontitis
Aggression
Aggressive Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Behavioral Symptoms