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Hexarelin

Examorelin, HEX

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Studies 233
Trials 61
Unknown NA INTERVENTIONAL NCT04343066

Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

The aim of this prospective controlled clinical trial is to evaluate the clinical and radiographical outcomes of two implant surfaces inserted in a crest that has been horizontally augmented at least 6 months prior to the implant placement. The horizontal GBR should be done with a xenogenic graft mixed with autologous bone particles, and a collagen membrane stabilized using tacks or screws.

Detailed Description

This is a prospective, randomized clinical and radiographical evaluation of bone remodeling around implants with two different surfaces placed in a previously augmented crest. Patients requiring dental implants in previously horizontally augmented bone crest are recruited at the Department of Periodon¬tics, Faculty of dental medicine, Saint-Joseph University, Beirut, and will be treated with either T3 (contemporary hybrid collar), tapered, ex-hex, CP4 or Full Osseotite, tapered, ex-hex, CP4. A total of 30 implants will be placed (15 per group). Random allocation of implant type per site will be done by the sealed envelope method. The implants will be placed using a one-stage surgical approach. A final crown will be placed (screw-retained on multiunit abutment) between 3 and 4 months post-implant placement. The patients will be followed-up at 6 months and 1 year. Only patients meeting inclusion/exclusion criteria and providing a dated and signed informed consent form will be enrolled in the study.

Interventions

Name: Implant insertion
Type: DEVICE
Description: In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites. A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement. Random allocation of implant type per site will be done by the sealed envelope method. Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process. Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking \< 10 cigarettes, previous horizontal bone augmentation, FMBS \<20% and FMPS \< 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis.

Primary Outcomes

Measure: Change from baseline of alveolar ridge thickness at 4 months
TimeFrame: During procedure and at 4 months
Description: Peroperative surgical measurements of the alveolar ridge width at implant sites
Measure: Change from baseline of radiographic bone level on CBCT at 1 year post-op
TimeFrame: During procedure and at 1 year
Description: CBCT for buccal bone thickness measurements of the bone crest width at the implant site.
Measure: Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray
TimeFrame: During procedure, at 4 months, at 6 months and 1 year
Description: Radiographic measurements on standardized periapical radiograph of the bone dimensions, for interproximal bone remodeling, from the shoulder of the implant (reference point), to the coronal bone to implant contact
Measure: Change from baseline of bone plate thickness at 4 months
TimeFrame: During procedure and at 4 months
Description: Peroperative buccal and lingual residual bone thickness following implant insertion

Trial Information

NCT ID

NCT04343066

Status

Unknown

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Saint-Joseph University

Last Updated

December 15, 2025