- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07670559
Carrot Technique Versus Guided Bone Regeneration for Horizontal Ridge Deficiency in the Maxillary Esthetic Zone
Evaluation of the Carrot Technique With Simultaneous Implant Placement for Horizontal Alveolar Ridge Deficiency in the Maxillary Aesthetic Zone: A Randomized Controlled Clinical Trial.
Studieöversikt
Status
Intervention / Behandling
Detaljerad beskrivning
The Carrot Technique is a minimally invasive approach that utilizes an autogenous bone core harvested during implant osteotomy and repositioned to augment the deficient buccal ridge. This technique may reduce donor-site morbidity while providing sufficient horizontal bone augmentation. Guided Bone Regeneration remains one of the most widely used techniques for horizontal ridge reconstruction through the use of bone substitute materials and barrier membranes.
This randomized controlled clinical trial will compare the clinical and radiographic outcomes of the Carrot Technique and GBR in patients presenting with horizontal ridge deficiency in the maxillary esthetic zone. Twenty patients requiring single-tooth implant rehabilitation will be randomly allocated into two equal groups. Group I will receive implant placement combined with the Carrot Technique, while Group II will receive implant placement combined with Guided Bone Regeneration.
Clinical evaluations will include implant stability assessed by resonance frequency analysis, soft tissue healing using the Landry Healing Index, and peri-implant inflammation using the modified sulcus bleeding index. Radiographic evaluation will be performed using cone beam computed tomography immediately after surgery and at 6 and 12 months postoperatively to assess changes in alveolar ridge width, bone density, and marginal bone loss. The study aims to determine whether the Carrot Technique provides comparable or superior outcomes to GBR for horizontal ridge augmentation associated with implant placement.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Al Mansurah, Egypten
- Faculty of Dentistry, Mansoura University
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypten, 35511
- Faculty of Dentistry, Mansoura University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Patients aged 18 to 45 years. Missing a single tooth in the maxillary esthetic zone requiring implant placement.
Good oral hygiene and patient compliance. Medically free from systemic diseases that contraindicate implant surgery. Slight to moderate horizontal alveolar ridge deficiency with a minimum ridge width of 5 mm.
Adequate vertical bone height for implant placement. Medium to hard bone quality (D2-D3 according to Misch classification). Absence of bruxism or other parafunctional habits.
Exclusion Criteria:
- Presence of local pathological lesions (e.g., cysts or tumors) at the planned surgical site.
Poor bone quality (D4 bone). Pregnancy. Heavy smoking. Any medical condition contraindicating implant surgery.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Carrot Technique
Implant placement with horizontal ridge augmentation using an autogenous bone core harvested with a trephine drill from the implant osteotomy site and fixed buccally using osteosynthesis screws.
|
Implant placement with simultaneous horizontal ridge augmentation using an autogenous bone core harvested from the implant osteotomy site with a trephine drill and fixed buccally using osteosynthesis screws.
|
|
Aktiv komparator: Guided Bone Regeneration
Implant placement with horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
|
Implant placement with simultaneous horizontal ridge augmentation using bone substitute material and a collagen membrane according to guided bone regeneration principles.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Alveolar Ridge Width
Tidsram: baseline and 12 Months
|
Horizontal alveolar ridge width measured using cone beam computed tomography (CBCT).
Changes in ridge width will be calculated by comparing measurements obtained immediately after surgery and at follow-up.
|
baseline and 12 Months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Marginal Bone Loss
Tidsram: 12 Months
|
Marginal bone loss measured radiographically using CBCT using the implant as a reference.
|
12 Months
|
|
Soft Tissue Healing
Tidsram: 1 Week, 2 Weeks, and 1 Month
|
Soft tissue healing assessed using the Landry Healing Index.
|
1 Week, 2 Weeks, and 1 Month
|
|
Modified Sulcus Bleeding Index
Tidsram: 1 Month and 12 Months
|
Peri-implant soft tissue inflammation assessed using the Modified Sulcus Bleeding Index (mBI).
|
1 Month and 12 Months
|
|
Bone Density
Tidsram: 12 Months
|
Buccal peri-implant bone density measured using CBCT and expressed in Hounsfield Units.
|
12 Months
|
|
Implant Stability Quotient (ISQ)
Tidsram: At implant placement and 12 months
|
Implant stability assessed using resonance frequency analysis and expressed as Implant Stability Quotient (ISQ).
|
At implant placement and 12 months
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Sarah A Elmaghraby, Faculty of Dentistry, Mansoura University, Mansoura, Egypt
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
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
Nyckelord
Andra studie-ID-nummer
- R.26.02.103
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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 .