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Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

22 oktober 2020 uppdaterad av: Nada BOU ABBOUD NAAMAN, Saint-Joseph University

Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

Studieöversikt

Status

Okänd

Betingelser

Intervention / Behandling

Detaljerad beskrivning

This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest.

Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4.

A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method.

The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement.

The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.

Studietyp

Interventionell

Inskrivning (Förväntat)

15

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Libanon
      • Beirut, Libanon, 1104 2020
        • Saint-Joseph University

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

20 år till 65 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  • Patient age: between 20 and 65
  • No systematic contraindication for implant surgery
  • No more than 10 cigarettes/day
  • Previous horizontal bone augmentation 6 months prior to implant placement
  • Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%)

Exclusion Criteria:

  • Smokers more than 10 cigarettes/day
  • Pregnant/lactating women
  • Alcoholics/drug addicts
  • Uncontrolled diabetics, immunocompromised, blood hemostasis problems
  • Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
  • Patients not willing to sign the consent form
  • History of radiotherapy in the head and neck region in the last 5 years
  • Active periodontitis on the remaining teeth

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: External hex implant
External hexagone implant connection
Enhet: Implant insertion

In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites.

A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement.

Random allocation of implant type per site will be done by the sealed envelope method.

Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process.

Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Andra namn:
  • Radiological bone level
Experimentell: Internal hex implant
Internal implant connection
Enhet: Implant insertion

In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites.

A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement.

Random allocation of implant type per site will be done by the sealed envelope method.

Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process.

Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Andra namn:
  • Radiological bone level

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change from baseline of alveolar ridge thickness at 4 months
Tidsram: During procedure and at 4 months
Peroperative surgical measurements of the alveolar ridge width at implant sites
During procedure and at 4 months
Change from baseline of radiographic bone level on CBCT at 1 year post-op
Tidsram: During procedure and at 1 year
CBCT for buccal bone thickness measurements of the bone crest width at the implant site.
During procedure and at 1 year
Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray
Tidsram: During procedure, at 4 months, at 6 months and 1 year
Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact
During procedure, at 4 months, at 6 months and 1 year
Change from baseline of bone plate thickness at 4 months
Tidsram: During procedure and at 4 months
Peroperative buccal and lingual residual bone thickness following implant insertion
During procedure and at 4 months

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Insertion torque
Tidsram: During procedure
Manual torque insertion are registered at implant placement.
During procedure
Change of Clinical parameters from baseline to 1 year post-op
Tidsram: During procedure, at 6 months and at 1 year
FMBS, FMPS,
During procedure, at 6 months and at 1 year
Change of FMBS parameters from baseline to 1 year post-op
Tidsram: During procedure, at 6 months and at 1 year
Change in full mouth bleeding score
During procedure, at 6 months and at 1 year
Change of Keratinized tissue height from Baseline to 4 months
Tidsram: During procedure and at 4 months
Measured using a 1.0-mm marked periodontal probe
During procedure and at 4 months
Histological analysis
Tidsram: During procedure
Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality
During procedure
Change of FMPS parameters from baseline to 1 year post-op
Tidsram: During procedure, at 6 months and at 1 year
Change in full mouth plaque score
During procedure, at 6 months and at 1 year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Saint-Joseph University

Utredare

  • Huvudutredare: Nada Naaman, PhD, Saint-Joseph University

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

15 april 2019

Primärt slutförande (Faktisk)

30 november 2019

Avslutad studie (Förväntat)

30 december 2020

Studieregistreringsdatum

Först inskickad

3 april 2020

Först inskickad som uppfyllde QC-kriterierna

8 april 2020

Första postat (Faktisk)

13 april 2020

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

23 oktober 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 oktober 2020

Senast verifierad

1 oktober 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Andra studie-ID-nummer

  • FMD195

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

The outcome measurements and patients characteristics might be shared

Tidsram för IPD-delning

1 year from date of publication

Kriterier för IPD Sharing Access

Following a direct request, for meta-analysis or literature review report.

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF
  • CSR

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Ja

produkt tillverkad i och exporterad från U.S.A.

Ja

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