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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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-
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Al Mansurah, Egypten
- Faculty of Dentistry, Mansoura University
-
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap.
|
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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Experimentell: 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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Inget ingripande: Immediate mandibular molar implant placement without grafting material.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Linear and Volumetric Digital Evaluation of implant site
Tidsram: preoperative, 1 month, 3 months and 6 months postoperative.
|
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.
|
preoperative, 1 month, 3 months and 6 months postoperative.
|
|
Radiographic Evaluation of Implant Site Volumetric Change
Tidsram: preoperatively, immediately after implant placement, and at 6 months
|
CBCT examinations obtained and three-dimensional superimposition of baseline and follow-up DICOM datasets used to evaluate hard-tissue dimensional changes.
|
preoperatively, immediately after implant placement, and at 6 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Implant Stability
Tidsram: at implant placement, 3 months and 6 months postoperative.
|
Implant stability assessment using resonance frequency analysis with the Osstell device to record implant stability quotient (ISQ) values.
|
at implant placement, 3 months and 6 months postoperative.
|
|
Modified Sulcus Bleeding Index
Tidsram: at 3 and 6 months postoperative.
|
Evaluation of peri-implant soft-tissue health using the modified sulcus bleeding index (mSBI).
|
at 3 and 6 months postoperative.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- A01012024OS
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