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

NCT04043286 | Completed Results FDA Device

• 1 other identifier: 5190024
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Loss; Implant Complication; Gingival Recession

Keywords

One abutment one time; Disconnection and reconnection; Definitive abutment

Outcome Measures

Primary Outcomes (1)

• Changes in Peri-implant Marginal Bone Level Between 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.

  At baseline (implant placement) and 1 year follow up

Secondary Outcomes (3)

• Changes in Keratinized Mucosa Width

  At baseline (implant placement) and 1 year follow up

• Changes in Lingual Mucosa Thickness

  At baseline (implant placement) and 1 year follow up

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

  12 months after surgical implantation

Study Arms (2)

Control group

NO INTERVENTION

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

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

Device: Definitive abutment

Interventions

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

Also known as: On1 Base, On1 Concept

Test group

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• Nobel Biocare: collaborator

Study Sites (1)

Loma Linda University, School of Dentistry

Loma Linda, California, 92350, United States

Location

Related Publications (57)

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MeSH Terms

Conditions

Bone Diseases, Metabolic; Gingival Recession

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Results Point of Contact

• Title: Dr. Sasiya Bhumpattarachai
• Organization: Loma Linda University, School of Dentistry

sbhumpattarachai@llu.edu

6267565156

Study Officials

• Joseph Kan, DDS, MS

  Loma Linda University School of Dentistry

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single center, prospective, randomized modified split mouth clinical trial

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 2, 2019
• Study Start: September 30, 2019
• Primary Completion: September 18, 2023
• Study Completion: September 18, 2023
• Last Updated: December 4, 2024
• Results First Posted: December 4, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)