Clinical trial NCT04043286: The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels
Official title: The Effects of Disconnection and Reconnection of Definitive Abutments on Peri-Implant Bone Levels: A 1-year Split-Mouth Randomized Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone Loss
Implant Complication
Gingival Recession
Keywords: One abutment one time
Disconnection and reconnection
Definitive abutment
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Nobel Biocare
First posted: 2019-08-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single center, prospective, randomized modified split mouth clinical trial
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the effects of definitive abutment connection at the time of implant placement on peri-implant bone levels and soft tissue changes in posterior maxilla and mandible regions.

Detailed description: A total of 38 implants were placed in 17 patients with at least 2 missing posterior teeth in the maxilla or the mandible for this study. Each patient received 2 or 4 implants. A definitive prefabricated abutment (test group) was randomly connected to one implant at implant placement (T0) and left undisturbed throughout the duration of the study. On the other implant, a healing abutment (control group) was connected and subjected to go through three disconnections and reconnections at 3 months (T3), 6 months (T6), and 12 months (T12) after the implant placement. Throughout the study period (1 year), all implants remained unrestored. Marginal bone level changes (MBLC) were assessed using standardized periapical radiographs taken at T0 and T12. Peri-implant soft tissue parameters including the keratinized mucosa width and lingual mucosa thickness were also recorded and evaluated.

Eligibility criteria: Inclusion Criteria:

* Minimum age 18
* Good oral hygiene
* Healed site that possess two or more missing teeth in the maxillary or mandibular posterior region (excluding third molars)
* Adequate bone to accommodate at least a 4.3 mm diameter and 8mm length implant at each site
* Have at least 8mm interocclusal restorative space
* Willing to participate and attend the planned follow-up visits.

Exclusion Criteria:

* History of alcohol/drug dependency, or any medical, physical, or psychological factor that might affect the surgical or prosthodontic procedures and follow-up examinations
* History of radiation therapy to the head and neck region
* History or current habit of smoking
* History or current habit of bruxism
* No opposing occluding dentition or prostheses
* Need for bone augmentation during implant placement
* Implant insertion torque value \<35 Ncm

Primary outcomes:
measure: Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up
timeFrame: At baseline (implant placement) and 1 year follow up
Secondary outcomes:
measure: Changes in Keratinized Mucosa Width
timeFrame: At baseline (implant placement) and 1 year follow up
measure: Changes in Lingual Mucosa Thickness
timeFrame: At baseline (implant placement) and 1 year follow up
measure: Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP)
timeFrame: 12 months after surgical implantation
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University, School of Dentistry
state: California
Study officials:
affiliation: Loma Linda University School of Dentistry
name: Joseph Kan, DDS, MS
role: PRINCIPAL_INVESTIGATOR
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