- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07697066
Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile
Influence of Different Customized Healing Abutment Materials on Peri-Implant Soft Tissue Profile
Studieöversikt
Status
Detaljerad beskrivning
A dental implant is a method for the replacement of lost teeth, with an excellent prospering percentage plus lasting functional rehabilitation without requiring any preparation of the nearby teeth.
The usage of a healing abutment is one of the crucial clinical procedures that follows implant placement. It aids in establishing a stable and natural gingival emergence profile by supporting soft tissue shaping and shielding the implant platform. Various materials are available for healing abutments, which have an impact on biocompatibility, aesthetic results, soft tissue reaction, and patient comfort throughout the healing process.
Polyether ether ether ketone (PEEK) healing abutments are offering a non-metallic, lightweight option with a modulus of elasticity similar to bone, but they have lower surface hardness compared to titanium and zirconia, and long-term data is still developing.
3D printed hybrid resin materials were introduced earlier, allowing faster and precise fabrication of permanent dental restorations. P-Crown V4 material is a newly introduced 3D-printed nanoceramic-filled resin reported to contain up to 70% nanoceramic filler to enhance strength and hardness.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
El-Gharbia
-
Tanta, El-Gharbia, Egypten, 31773
- Tanta University - Faculty of Dentistry
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Patient's aged 25-45 years old
- Patients with missing tooth needing solitary implant placement rehabilitation in the maxillary anterior regions with neighboring and opposite normal teeth.
- Adequate mesial, distal, and interocclusal space for implant engagement and its absolute re-establishment.
- Patients can recite and mark the informed approval paper.
- Medically free patients or with controlled systemic disease.
- Patients with acceptable bone quality and quantity.
- Patients can return for follow-up examinations and evaluation.
- Patients with good oral hygiene.
- Nasal floor clearance from root apex at least 4 mm.
Exclusion Criteria:
- Patients with inappropriate implantation situates (patients with foremost bony deficiencies or sever bone resorption).
- Patient with severe clenching or bruxism.
- Heavy smokers or drug abusers.
- Psychiatric complications or impractical prospects.
- Patients with bad oral hygiene.
- Systemic conditions that may impact soft or hard tissue curing.
- Patients with history of radiation treatment in the head and neck area.
- Pregnant female
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group I
Patients received a standard ready-made titanium healing abutment (control group).
|
Patients received a standard ready-made titanium healing abutment (control group).
|
|
Experimentell: Group II
Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.
|
Patients received a customized healing abutment of milled Polyetheretherketone (PEEK) material.
|
|
Experimentell: Group III
Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.
|
Patients received a customized healing abutment of 3D-printed hybrid resin (P crownV4) material.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified Plaque Index
Tidsram: Two months after healing abutment placement
|
The Modified Plaque Index was used to assess the degree of Plaque Accumulation. 0 No plaque
|
Two months after healing abutment placement
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Modified gingival index
Tidsram: Two months after healing abutment placement
|
The modified gingival index was used to assess the gingival condition. Each surface was evaluated and assigned a score from 0 to 4: 0 No bleeding
|
Two months after healing abutment placement
|
|
Papilla index (Jemt Index)
Tidsram: Two months after healing abutment placement
|
The papilla index (Jemt Index) was used to assess the Papilla condition. 0 No papilla present; no soft tissue curvature; empty space present.
|
Two months after healing abutment placement
|
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
- R-FP-11-25-3233
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .