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Completed

NCT Number: NCT04043286

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

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.

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Key information

Conditions

Bone Loss Bone Diseases Bone Diseases, Metabolic Gingival Diseases Gingival Recession Implant Complication Metabolic Diseases Mouth Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University, School of Dentistry

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Definitive abutment

Device

With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures

Other names: On1 Base, On1 Concept

Primary outcomes

  1. Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up

    Time frame: At baseline (implant placement) and 1 year follow up

    Standardized digital periapical radiographs were taken at baseline (implant placement) and at the 1-year follow-up using the long-cone paralleling technique with a custom jig. Peri-implant marginal bone levels were measured on both the mesial and distal aspects to assess bone loss. Changes in peri-implant marginal bone levels were calculated by comparing the measurements at the 1-year follow-up to the baseline values.

Secondary outcomes

  1. Changes in Keratinized Mucosa Width

    Time frame: At baseline (implant placement) and 1 year follow up

    The width of the keratinized mucosa was measured at the mid-buccal aspect of the abutments using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values.

  2. Changes in Lingual Mucosa Thickness

    Time frame: At baseline (implant placement) and 1 year follow up

    The thickness of the lingual mucosa at each implant site was measured at the center of the implant site from the bone crest using a periodontal probe with 1.0 mm markings. Measurements were repeated at the 1-year follow-up at the same location and compared to the baseline values taken on the day of implant surgery.

  3. Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP)

    Time frame: 12 months after surgical implantation

    Success was determined by the implant's ability to meet these clinical factors, such as the absence of pain, infection, mobility, and radiographic bone loss beyond the acceptable threshold of the follow-up period, as assessed at 12 months post-surgical implantation.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • Nobel Biocare

Registry information

Official study title

The Effects of Disconnection and Reconnection of Definitive Abutments on Peri-Implant Bone Levels: A 1-year Split-Mouth Randomized Controlled Clinical Study

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Aug 2, 2019
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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