Radiographic and the Esthetic Outcome of Two Different Bone Grafting Techniques in Early Implant Placement

NCT03302143 | Completed DMC

• 1 other identifier: HSC20120264H
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

Total of 48 subjects were randomly assigned to treatment groups: UT Health Science Center at San Antonio Chi Mei Medical Center, Tainan, Taiwan Patients require a maxillary non-molar extraction site that is planned to be replaced by a dental implant and crown. This includes Straumann BL SLActive: Narrow (3.3mm) \& Regular (4.1mm) Crossfit implants in all available lengths. Patients were randomly selected to receive either FDBA (test) or Autogenous bone + DBBM (control/standard) for contour augmentation.

Conditions

Missing Tooth; Fractured Tooth

Keywords

Dental Implant; Guided Bone Regeneration; Contour Augmentation

Outcome Measures

Primary Outcomes (1)

• Facial bone thickness

  Facial bone thickness 1 year post-loading at 1, 3, and 5mm from the implant platform

  Measured at 1 year post-loading

Secondary Outcomes (5)

• Change in facial bone thickness

  Between implant placement and 1 year post-loading

• mPI measurement

  Measured at 6 and 12-months post-loading

• PD measurement

  Measured at 6 and 12-months post-loading

• mSBI measurement

  Measured at 6 and 12-months post-loading

• KM measurement

  Measured at 6 and 12-months post-loading

Study Arms (2)

Control

ACTIVE COMPARATOR

Guided bone regeneration with Bovine Bone Mineral

Procedure: Guided bone regeneration with Bovine Bone Mineral

Experimental

EXPERIMENTAL

Guided bone regeneration with freeze dried bone allograft

Procedure: Guided bone regeneration with freeze dried bone allograft

Interventions

Guided bone regeneration with Bovine Bone Mineral PROCEDURE

Guided bone regeneration with Bovine Bone Mineral

Control

Guided bone regeneration with freeze dried bone allograft PROCEDURE

Guided bone regeneration with freeze dried bone allograft

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient is 18 years or older.
• Non-smoker or patient has smoking habit and \< 1 pack per day.
• Ability to understand and provide informed consent before starting the study.
• Ability and willingness to comply with all study requirements.
• The patient, if of child-bearing potential, has a negative urine pregnancy test.
• Adequate oral hygiene to allow for implant therapy consistent with standards of care.
• Adequate primary stability following early implant placement protocols utilizing Straumann Bone Level implants NC 3.3mm or RC 4.1mm in diameter at all available implant lengths.
• One or more teeth in maxilla (11,12,13,14,15,21,22,23,24,25 according to FDI) has been identified as having a hopeless prognosis requiring extraction leading to a single-tooth gap requiring implant placement as determined by clinician.
• Implant site that has a defect and requires bone augmentation. This will be determined by measuring on the CBCT image the available space for the implant and whether or not there is enough bone width where the implant is to be placed.

You may not qualify if:

• Patient reports current smoking habit \> 1 pack per day or tobacco chewing use.
• History of alcoholism or drug abuse within the past 5 years.
• Severe bruxism or clenching habits.
• Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
• History of HIV infection, Hepatitis B or C.
• Patients with a history of systemic disease that precludes standard dental implant therapy.
• Presence of local inflammation or mucosal diseases such as lichen planus
• Patient history consistent with high risk for subacute bacterial endocarditis
• Current hematological disorder or coumadin (or similar) therapy
• Patient currently undergoing chemotherapy
• Patient history of radiation treatment to the head or neck
• Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis
• Pregnant or breastfeeding women

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

MeSH Terms

Conditions

Anodontia; Tooth Fractures

Condition Hierarchy (Ancestors)

Tooth Abnormalities; Stomatognathic System Abnormalities; Stomatognathic Diseases; Tooth Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Tooth Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A comparative, randomized, prospective, clinical study

Study Record Dates

• First Submitted: September 26, 2017
• First Posted: October 4, 2017
• Study Start: July 30, 2013
• Primary Completion: May 15, 2016
• Study Completion: May 15, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-09