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

Not Applicable

• Conditions: Dental Implantation; Bone Remodeling
• Interventions: Device: Implant insertion

• Registration Number: NCT04343066
• Lead Sponsor: Saint-Joseph University

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.

Study Timeline

• Study Start: 2019-04-15
• Primary Completion: 2019-11-30
• Study First Submitted: 2020-04-03
• Study First Submitted QC: 2020-04-08
• Study First Posted: 2020-04-13
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patient age: between 20 and 65
• No systematic contraindication for implant surgery
• No more than 10 cigarettes/day
• Previous horizontal bone augmentation 6 months prior to implant placement
• Adequate oral hygiene i.e. Full mouth bleeding score (FMBS) <20% and Full mouth plaque score (FMPS) < 20%)

Exclusion Criteria

• Smokers more than 10 cigarettes/day
• Pregnant/lactating women
• Alcoholics/drug addicts
• Uncontrolled diabetics, immunocompromised, blood hemostasis problems
• Patients taking IV bisphosphonates or drugs affecting bone metabolism or mucosal healing
• Patients not willing to sign the consent form
• History of radiotherapy in the head and neck region in the last 5 years
• Active periodontitis on the remaining teeth

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Internal hex implant	Implant insertion	Internal implant connection
External hex implant	Implant insertion	External hexagone implant connection

Primary Outcome Measures

Name	Time	Method
Change from baseline of radiographic bone level assessment at 1 year post-op, on periapical x-ray	During procedure, at 4 months, at 6 months and 1 year	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
Change from baseline of alveolar ridge thickness at 4 months	During procedure and at 4 months	Peroperative surgical measurements of the alveolar ridge width at implant sites
Change from baseline of radiographic bone level on CBCT at 1 year post-op	During procedure and at 1 year	CBCT for buccal bone thickness measurements of the bone crest width at the implant site.
Change from baseline of bone plate thickness at 4 months	During procedure and at 4 months	Peroperative buccal and lingual residual bone thickness following implant insertion

Secondary Outcome Measures

Name	Time	Method
Insertion torque	During procedure	Manual torque insertion are registered at implant placement.
Change of FMBS parameters from baseline to 1 year post-op	During procedure, at 6 months and at 1 year	Change in full mouth bleeding score
Histological analysis	During procedure	Bone core taken with a 2mm trephine bur at the site of implant placement for non-demineralized histological assessment of regenerated bone quality
Change of Clinical parameters from baseline to 1 year post-op	During procedure, at 6 months and at 1 year	FMBS, FMPS,
Change of Keratinized tissue height from Baseline to 4 months	During procedure and at 4 months	Measured using a 1.0-mm marked periodontal probe
Change of FMPS parameters from baseline to 1 year post-op	During procedure, at 6 months and at 1 year	Change in full mouth plaque score

Trial Locations

Locations (1)

Saint-Joseph University; 🇱🇧 Beirut, Lebanon