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Immediate Implant Placement in Aggressive Periodontitis (implant)

14. juli 2017 opdateret af: nermin mohammed ahmed yussif, Cairo University

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

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.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / 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 navne:
  • implants in aggressive periodontitis
Eksperimentel: 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 navne:
  • implants in aggressive periodontitis

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studieleder: mona darhous, Prof, Faculty of Oral and Dental Medicine Cairo University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

10. juni 2017

Primær færdiggørelse (Forventet)

8. august 2018

Studieafslutning (Forventet)

8. december 2018

Datoer for studieregistrering

Først indsendt

3. juli 2017

Først indsendt, der opfyldte QC-kriterier

12. juli 2017

Først opslået (Faktiske)

14. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. juli 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2017

Sidst verificeret

1. juli 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • immediate implant

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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