NCT03218228

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2018

Completed
Last Updated

July 18, 2017

Status Verified

July 1, 2017

Enrollment Period

1.2 years

First QC Date

July 3, 2017

Last Update Submit

July 14, 2017

Conditions

Keywords

aggressive periodontitis

Outcome Measures

Primary Outcomes (1)

  • 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).

    12 months following implant placement

Secondary Outcomes (1)

  • midfacial peri-implant mucosal level

    12 months following implant placement

Study Arms (2)

implants in healthy individuals

PLACEBO COMPARATOR

immediate placement of dental implants in individuals with healthy periodontium. the device is dental implants, radiographs, william's periodontal probe

Procedure: implants in periodontitis

implants in periodontitis patients

EXPERIMENTAL

immediate implantation in patients suffering from aggressive periodontitis. the device is the dental implants, radiographs, william's periodontal probe

Procedure: implants in periodontitis

Interventions

it targets immediate implant placement in patients suffering from aggressive periodontitis

Also known as: implants in aggressive periodontitis
implants in healthy individualsimplants in periodontitis patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged above 18 years old.
  • Patients should be free from any systemic disease.
  • patients with good oral hygiene
  • completely or partially edenthulus patients

You may not qualify if:

  • Current and former smokers.
  • Pregnant females.
  • Patients with systemic diseases that may interfere with periodontal condition
  • Uncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Octobar University of Modern Sciences and Arts

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

PeriodontitisAggressive Periodontitis

Interventions

Drug Implants

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Delayed-Action PreparationsDosage FormsPharmaceutical Preparations

Study Officials

  • mona darhous, Prof

    faculty of oral and dental medicine cairo university

    STUDY DIRECTOR

Central Study Contacts

nermin M yussif, TA

CONTACT

ahmed reda, T

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator-faculty of oral and dental medicine

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 14, 2017

Study Start

June 10, 2017

Primary Completion

August 8, 2018

Study Completion

December 8, 2018

Last Updated

July 18, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations