Beta-Tricalcium Phosphate Grafting of Peri-implant Jumping Gaps Greater Than 2 mm in Immediate Implants
Effect of Beta-Tricalcium Phosphate (β-TCP) Grafting on Implant Stability and Peri-implant Bone Density Following Immediate Implant Placement in Sites With Jumping Gaps Exceeding 2 mm: A Randomized Controlled Trial
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Design: single-center, prospective, parallel-group, randomized controlled trial with a 1:1 allocation ratio. Ethical approval was obtained from the Research Ethics Committee, Faculty of Dentistry, Suez Canal University (approval no. 682/2023), and all procedures were performed in accordance with the Declaration of Helsinki. Written informed consent was obtained from all participants.
Participants: patients aged 20-50 years requiring extraction of a non-restorable maxillary anterior or premolar root, with a peri-implant jumping gap greater than 2 mm at the implant site.
Interventions: after atraumatic extraction and prosthetically driven osteotomy preparation, implants were placed at the crestal level. In the test group the peri-implant gap was filled with injectable β-TCP; in the control group no grafting was performed.
Randomization and blinding: the allocation sequence was computer-generated by an investigator not involved in surgery, with concealment by sequentially numbered, opaque, sealed envelopes. Outcome assessors, including the radiographic bone-density readers, were blinded to group allocation.
Outcomes: the primary outcome was implant stability (ISQ) at baseline, 3, and 6 months. Secondary outcomes were peri-implant bone density on periapical radiographs (Digora grayscale, 0-255) and on a single 6-month CBCT (gray-value-derived HU-equivalent radiodensity), and implant survival. Analysis used independent-samples t tests for between-group and repeated-measures ANOVA for within-group comparisons (α = 0.05), with the patient as the unit of analysis.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ismailia, Egypten
- Department of Oral and Maxillofacial Surgery, Faculty of Dentistry, Suez Canal University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Age 20 to 50 years
- Non-restorable maxillary anterior or premolar tooth requiring extraction and immediate implant placement
- Peri-implant jumping gap greater than 2 mm at the implant site
- Adequate inter-arch space
- Good patient compliance
Exclusion Criteria:
• Systemic disease affecting healing
- Smoking of more than 10 cigarettes per day
- Parafunctional habits
- Poor oral hygiene
- Active periodontal disease
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: control; no grafting
Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with no grafting of the peri-implant gap.
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Eksperimentel: Test: beta-tricalcium phosphate grafting
Immediate implant placement in a site with a peri-implant jumping gap greater than 2 mm, with the gap filled with injectable β-tricalcium phosphate (β-TCP) after implant placement.
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A β-tricalcium phosphate synthetic bone substitute supplied ready-to-use in a putty carrier (Bonegraft Biomaterials Co., Ltd., Daegu, South Korea), placed into the peri-implant jumping gap (greater th
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Implant stability (implant stability quotient, ISQ)
Tidsramme: Baseline (immediately postoperative), 3 months, and 6 months
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Implant stability measured by resonance frequency analysis and expressed as the ISQ (unitless, 1-100; higher = more stable).
The patient was the unit of analysis; for patients with more than one implant, the mean ISQ of that patient's implants was used.
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Baseline (immediately postoperative), 3 months, and 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Peri-implant bone density on periapical radiographs (Digora grayscale)
Tidsramme: Baseline, 3 months, and 6 months
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Bone density on standardized digital periapical radiographs (paralleling technique, fixed exposure), analyzed with Digora software as grayscale values (0-255) at the mesial, distal, and apical regions.
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Baseline, 3 months, and 6 months
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Peri-implant radiodensity on 6-month cone-beam CT (HU-equivalent)
Tidsramme: 6 month
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Radiodensity on a single 6-month CBCT along the buccal aspect of each implant at apical, middle, and crestal levels, expressed as gray-value-derived HU-equivalent values; read independently by two blinded radiologists.
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6 month
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Implant survival
Tidsramme: 6 months
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Proportion of implants surviving to the 6-month follow-up, with assessment of infection, implant mobility, and wound dehiscence at each visit.
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6 months
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 682/2023
Plan for individuelle deltagerdata (IPD)
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