The Effects of Dis/Reconnection of Implant Abutments on Peri-implant Bone Levels

Loma Linda University (LLU)

Status: Completed

Conditions: Gingival Recession; Implant Complication; Bone Loss

Treatments: Device: Definitive abutment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04043286

5190024

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 2 patient groups

Control group

No Intervention group

Description:

Split mouth: Healing abutments are connected on the implants on the day of surgery, which will be subjected to multiple disconnection and reconnection during the study

Test group

Experimental group

Description:

Split mouth: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase

Treatment:

Device: Definitive abutment