- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03218228
Immediate Implant Placement in Aggressive Periodontitis (implant)
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
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Giza, Egypt
- Rekruttering
- Octobar University of Modern Sciences and Arts
-
Ta kontakt med:
- nermin yussif, TA
- Telefonnummer: 01118271929
- E-post: dr_nermin_yusuf@yahoo.com
-
Ta kontakt med:
- rasha attia, TA
- Telefonnummer: 01009032255
- E-post: periorasha1@gmail.com
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Placebo komparator: implants in healthy individuals
immediate placement of dental implants in individuals with healthy periodontium.
the device is dental implants, radiographs, william's periodontal probe
|
it targets immediate implant placement in patients suffering from aggressive periodontitis
Andre navn:
|
|
Eksperimentell: implants in periodontitis patients
immediate implantation in patients suffering from aggressive periodontitis. the device is the dental implants, radiographs, william's periodontal probe
|
it targets immediate implant placement in patients suffering from aggressive periodontitis
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
implant and peri-implant tissues health
Tidsramme: 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).
|
12 months following implant placement
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
midfacial peri-implant mucosal level
Tidsramme: 12 months following implant placement
|
evaluattion of the mucosal level at the midfacial site of the immediately placed dental implants
|
12 months following implant placement
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: mona darhous, Prof, Faculty of Oral and Dental Medicine Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- immediate implant
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på implants in periodontitis
-
Ideal Implant IncorporatedFullførtBrystimplantaterForente stater
-
Apreo Health, Inc.FullførtEmfysem eller KOLSAustralia
-
Mardil MedicalUkjentFunksjonell Mitral RegurgitationTsjekkia, Frankrike
-
PolyActiva Pty LtdAktiv, ikke rekrutterendeOkulær hypertensjon (OH) | Åpenvinkelglaukom (OAG)Australia
-
Medical University of GrazFullført
-
Arrow DevelopmentSalud y Estetica Dental SCH Zurbano S.L; Clinica Dental Nexus, Malaga; Clinica... og andre samarbeidspartnereHar ikke rekruttert ennåPeri-implantitt | Bentap peri-implantat
-
Apreo Health, Inc.Aktiv, ikke rekrutterendeEmfysem eller KOLSStorbritannia, Nederland, Østerrike
-
Oticon MedicalTilbaketrukketCochlea hørselstap | Cochlea traume
-
Cukurova UniversityDentsply Sirona ImplantsUkjentAlveolært bentap | Post-osseointegrasjon biologisk svikt ved tannimplantatTyrkia