Clinical trial NCT04343066: Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone
Official title: Clinical and Radiographic Evaluation of Bone Remodeling Around Implants With Two Different Surfaces Placed in Horizontally Augmented Bone: a 1-year Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Implantation
Bone Remodeling
Keywords: Alveolar ridge augmentation
Dental implants
Marginal bone remodeling
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2020-04-13
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline of alveolar ridge thickness at 4 months
timeFrame: During procedure and at 4 months
measure: Change from baseline of radiographic bone level on CBCT at 1 year post-op
timeFrame: During procedure and at 1 year
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
measure: Change from baseline of bone plate thickness at 4 months
timeFrame: During procedure and at 4 months
Secondary outcomes:
measure: Insertion torque
timeFrame: During procedure
measure: Change of Clinical parameters from baseline to 1 year post-op
timeFrame: During procedure, at 6 months and at 1 year
measure: Change of FMBS parameters from baseline to 1 year post-op
timeFrame: During procedure, at 6 months and at 1 year
measure: Change of Keratinized tissue height from Baseline to 4 months
timeFrame: During procedure and at 4 months
measure: Histological analysis
timeFrame: During procedure
measure: Change of FMPS parameters from baseline to 1 year post-op
timeFrame: During procedure, at 6 months and at 1 year
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint-Joseph University
Study officials:
affiliation: Saint-Joseph University
name: Nada Naaman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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