Comparison Between Xenograft and Extended PRF as Jumping Gap Grafting Material Versus Natural Healing of the Socket Without Any Material.
Clinical and Digital Evaluation of Different Jumping Gap Grafting Materials Versus No Grafting Material in Immediate Lower Molar Implant Placement
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Following atraumatic extraction and implant site preparation within the interradicular bone, the implant will be immediately inserted. A chairside customized healing abutment will then be fabricated to seal the extraction socket. According to group allocation, the jumping gap will be filled with xenograft, e-PRF, or left unfilled before placement of the customized healing abutment. Definitive prosthetic restoration will be delivered after three months of implant insertion.
Clinical Evaluation:
Implant stability will be assessed at implant placement and at 3 and 6 months using resonance frequency analysis with the Osstell device, with implant stability quotient (ISQ) values recorded.
Peri-implant soft-tissue health will be assessed using the modified sulcus bleeding index (mSBI) at 3 and 6 months intervals.
Digital Evaluation:
Peri-implant soft-tissue dimensional changes will be assessed using intraoral optical scans obtained preoperatively and at 1, 3, and 6 months. The resulting STL files will be superimposed using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.
- Radiographic Evaluation:
CBCT examinations will be obtained preoperatively, immediately after implant placement, and at 6 months. Three-dimensional superimposition of baseline and follow-up DICOM datasets will be used to evaluate hard-tissue dimensional changes.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Al Mansurah, Egypte
- Faculty of Dentistry, Mansoura University
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Any partially dentate patients with non-restorable mandibular molar requiring dental extraction.
- Extraction sockets with intact bony walls and interradicular bone.
- Jumping gap more than 2mm.
Exclusion Criteria:
- Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
- Heavy smokers (≥ pack per day)
- Pregnancy.
- Patients with systemic diseases that absolutely contraindicate implant placement or para-functional habits (bruxism or clenching).
- Patients with poor oral hygiene or aggressive periodontal disease.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap.
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after tooth extraction and implant placement, xenograft particulates were placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
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Experimenteel: Ten immediate mandibular molar implant placement with e-PRF filling material of the jumping gap.
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after tooth extraction and implant placement, e-PRF was prepared from the patient's collected blood and placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
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Geen tussenkomst: Immediate mandibular molar implant placement without grafting material.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Linear and Volumetric Digital Evaluation of implant site
Tijdsspanne: preoperative, 1 month, 3 months and 6 months postoperative.
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Peri-implant soft-tissue dimensional changes assessment using intraoral optical scans and resulting STL files superimposition using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.
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preoperative, 1 month, 3 months and 6 months postoperative.
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Radiographic Evaluation of Implant Site Volumetric Change
Tijdsspanne: preoperatively, immediately after implant placement, and at 6 months
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CBCT examinations obtained and three-dimensional superimposition of baseline and follow-up DICOM datasets used to evaluate hard-tissue dimensional changes.
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preoperatively, immediately after implant placement, and at 6 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Implant Stability
Tijdsspanne: at implant placement, 3 months and 6 months postoperative.
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Implant stability assessment using resonance frequency analysis with the Osstell device to record implant stability quotient (ISQ) values.
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at implant placement, 3 months and 6 months postoperative.
|
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Modified Sulcus Bleeding Index
Tijdsspanne: at 3 and 6 months postoperative.
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Evaluation of peri-implant soft-tissue health using the modified sulcus bleeding index (mSBI).
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at 3 and 6 months postoperative.
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Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- A01012024OS
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
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