An interventional study of Definitive abutment in Bone Loss, Implant Complication and Gingival Recession, sponsored by Loma Linda University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Loma Linda University · Not applicable, Interventional, and Treatment
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.
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.
402 studies on the registry are indexed under Gingival Recession; 98 are open to participants now.
This study's enrollment of 19 is below the median of 30 across 368 interventional studies indexed under Gingival Recession.
Browse Gingival Recession studies →Loma Linda University is the lead sponsor of 297 studies on the registry; 48 are open to participants now.
Of its 28 completed or terminated interventional studies of FDA-regulated products, 23 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
Split mouth: Definitive abutments connected to the implants on the day of surgery. No disconnection or reconnection during the prosthetic phase
Device: Definitive abutment
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
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.
Time frame: At baseline (implant placement) and 1 year follow up
Changes in Keratinized Mucosa Width
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.
Time frame: At baseline (implant placement) and 1 year follow up
Changes in Lingual Mucosa Thickness
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.
Time frame: 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)
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.
Time frame: 12 months after surgical implantation
1. Read, sign, and receive a copy of the consent form. 2. Male or female, at least 18 years old, with good oral and general health. 3. Healed edentulous site with two or more missing teeth in the posterior maxilla or mandible (excluding third molars). 4. Adequate bone width and height for a 4.3 mm diameter, 8 mm length implant. 5. Have at least 8 mm restorative space. 6. Willing to participate and attend a 1-year follow-up before implant restoration procedures.
| Milestone | Control Group | Test Group |
|---|---|---|
| Started | 19 | 19 |
| Completed | 17 | 17 |
| Not completed | 2 | 2 |
| Withdrew: Withdrawal by subject | 2 | 2 |
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.
| millimeters | Control Group | Test Group |
|---|---|---|
| Changes in Peri-implant Marginal Bone Level Between Baseline (Implant Placement) and 1 Year Follow up | 0.80 ± 0.92 | 0.32 ± 0.47 |
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.
| millimeters | Control Group | Test Group |
|---|---|---|
| Changes in Keratinized Mucosa Width | 0.90 ± 0.77 | 0.42 ± 0.42 |
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.
| millimeters | Control Group | Test Group |
|---|---|---|
| Changes in Lingual Mucosa Thickness | 0.71 ± 0.59 | 0.38 ± 0.26 |
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.
| Implants | Control Group | Test Group |
|---|---|---|
| Implant Success Rate According to the 2017 Classification Criteria Set by the American Academy of Periodontology (AAP) | 0 | 0 |
Collected over 1 year. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Test Group | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Age, Continuous(years) | Split Mouth Subject |
|---|---|
| Mean | 64 ± 12 |
| Sex: Female, Male(Participants) | Split Mouth Subject |
|---|---|
| Female | 9 |
| Male | 8 |
| Race and Ethnicity Not Collected(Participants) | Split Mouth Subject |
|---|
| Region of Enrollment(participants) | Split Mouth Subject |
|---|---|
| United States | 17 |
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