Immediate Implant Placement in Aggressive Periodontitis (implant)
Primary Purpose
Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
implants in periodontitis
Sponsored by
About this trial
This is an interventional health services research trial for Periodontitis focused on measuring aggressive periodontitis
Eligibility 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
Sites / Locations
- Octobar University of Modern Sciences and ArtsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
implants in healthy individuals
implants in periodontitis patients
Arm Description
immediate placement of dental implants in individuals with healthy periodontium. the device is dental implants, radiographs, william's periodontal probe
immediate implantation in patients suffering from aggressive periodontitis. the device is the dental implants, radiographs, william's periodontal probe
Outcomes
Primary Outcome Measures
implant and peri-implant tissues health
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
midfacial peri-implant mucosal level
evaluattion of the mucosal level at the midfacial site of the immediately placed dental implants
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03218228
Brief Title
Immediate Implant Placement in Aggressive Periodontitis
Acronym
implant
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2017 (Actual)
Primary Completion Date
August 8, 2018 (Anticipated)
Study Completion Date
December 8, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
Keywords
aggressive periodontitis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
implants in healthy individuals
Arm Type
Placebo Comparator
Arm Description
immediate placement of dental implants in individuals with healthy periodontium. the device is dental implants, radiographs, william's periodontal probe
Arm Title
implants in periodontitis patients
Arm Type
Experimental
Arm Description
immediate implantation in patients suffering from aggressive periodontitis. the device is the dental implants, radiographs, william's periodontal probe
Intervention Type
Procedure
Intervention Name(s)
implants in periodontitis
Other Intervention Name(s)
implants in aggressive periodontitis
Intervention Description
it targets immediate implant placement in patients suffering from aggressive periodontitis
Primary Outcome Measure Information:
Title
implant and peri-implant tissues health
Description
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).
Time Frame
12 months following implant placement
Secondary Outcome Measure Information:
Title
midfacial peri-implant mucosal level
Description
evaluattion of the mucosal level at the midfacial site of the immediately placed dental implants
Time Frame
12 months following implant placement
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nermin M yussif, TA
Phone
01118271929
Email
dr_nermin_yussif@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed reda, T
Phone
01006608568
Email
dr.a.reda@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
mona darhous, Prof
Organizational Affiliation
faculty of oral and dental medicine cairo university
Official's Role
Study Director
Facility Information:
Facility Name
Octobar University of Modern Sciences and Arts
City
Giza
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
nermin yussif, TA
Phone
01118271929
Email
dr_nermin_yusuf@yahoo.com
First Name & Middle Initial & Last Name & Degree
rasha attia, TA
Phone
01009032255
Email
periorasha1@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Immediate Implant Placement in Aggressive Periodontitis
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