Teeth Loss
Conditions
Brief summary
This study will investigate the effect on the soft tissue that is in contact with a dental implant with a modified surface of the neck (the part of the implant that is above the bone and in contact with the soft gum tissue).
Detailed description
This is a prospective, controlled, randomised clinical pilot study with parallel groups and blinded subject. The design has been chosen to obtain data to base a sample size calculation for future studies on by comparing the degree of mucosal inflammation of the mucosa in conjunction with the modified surface of the top of the test implant and the machined surface on the top of the control implant.
Interventions
DEVICEStandard Plus ESTA STL Roxolid implant
The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
DEVICEStandard Plus STL implant
The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
Sponsors
Institut Straumann AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must have voluntarily signed the informed consent form before any study related action * Males and females must be at least 18 years of age and not more than 80 years old. * Partially edentulous in posterior (position 3-7) maxilla or mandible with implants planned for single crowns in an area with a healed extraction socket. * Adequate bone quality and quantity at the implant site to permit the insertion of a Straumann Soft Tissue Level implant of 4.1mm diameter without augmentation (at least 1mm bone buccally and lingually/palatal)
Exclusion criteria
* Oral surgery contraindicated according to the judgement of the investigator (should be explained in the CRF) * Local inflammation, including untreated periodontitis * Patients with inadequate oral hygiene or unmotivated for adequate home care. Full mouth plaque index \> 25% at time of surgery * Presence of conditions requiring chronic routine prophylactic use of antibiotics (e.g., history of rheumatic heart disease, bacterial endocarditis, cardiac valvular anomalies, prosthetic joint replacements) * Major systemic diseases * Medical conditions requiring prolonged use of steroids * Current pregnancy or breastfeeding women * Physical handicaps that would interfere with the ability to perform adequate oral hygiene * Use of any investigational drug or device within the 90 day period immediately prior to implant surgery on study day 0 * Alcoholism or chronically drug abuse * Smokers; more than 10 cigarettes per day * Immuno-compromised patients * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability. Secondary
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sulcus Bleeding Index (According to Mombelli et al 1987) | 12 months | The primary endpoint is the difference of Sulcus Bleeding Index (according to Mombelli et al 1987) between baseline (final loading) and 12 months. The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Soft Tissue Healing Evaluation | 10 days and 12 weeks | Assessment of the wound healing by classifying the implantation site (normal or compromised healing). |
| Oral Hygiene | Screening, 6, 12, 36 months | Full mouth plaque index (FMPI) and full mouth bleeding on probing index (FMBoP) will be recorded as an indicator for the Oral Hygiene. The indexes are given in percent \[%\] calculated as the total numbers of surfaces with plaque or bleeding divided by the total number of teeth surfaces x100. |
| Recession of Gingival Margin Buccally and Lingually/Palatal | 1 and 3 years | The recession of the gingival margin will be measured (distance from the gingival margin to the crown/implant margin) by using an UNC 15 periodontal probe. Changes in (averaged) recession at the follow-up visits 12+36 months compared to baseline visit ( final loading ) are displayed |
| Probing Pocket Depth (PPD) | 6 months, 1 and 3 years | The PPD will be measured from the mucosal margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Probing pocket depth (mm) - average over buccal, palatal, distal and mesial measurements. |
| Sulcus Bleeding Index (According to Mombelli et al 1987) | 3 years | The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding. |
| Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements | 1 and 3 years | Periapical radiographs are used to measure changes in mesial and distal bone crest levels (of the implant) from baseline (final loading) to one (1) year and three (3) years, respectively. The parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface, and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants on digitized standardized periapical x-rays using an image analysis computer programme. Bone levels are averaged over mesial+distal measurements. Since bone levels were measured from the implant shoulder, an increase in bone level over time corresponds to bone loss. |
| Dental Implant Success and Implant Loss | 3 years | The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success. |
| Adverse Events | up to 3 years | All subjects are monitored continuously for adverse event. |
| Clinical Attachment Level (CAL) | 6 months, 1 and 3 years | The CAL will be measured from the crown margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Clinical attachment level (mm) - average over buccal, palatal, distal and mesial measurements |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Plus ESTA STL Roxolid Implant This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA).
Standard Plus ESTA STL Roxolid implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded. | 22 |
| Standard Plus STL Implant This arm will receive the Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck.
Standard Plus STL implant: The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded. | 21 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Analysis After the 36 Months Follow-up | Adverse Event | 1 | 0 |
| Analysis After the 36 Months Follow-up | Death | 0 | 1 |
| Analysis After the 36 Months Follow-up | Protocol Violation | 2 | 1 |
| Analysis of Primary Endpoint (12 Mts) | Adverse Event | 1 | 0 |
| Analysis of Primary Endpoint (12 Mts) | Protocol Violation | 2 | 1 |
Baseline characteristics
| Characteristic | Standard Plus STL Implant | Total | Standard Plus ESTA STL Roxolid Implant |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 13 | 57 years STANDARD_DEVIATION 13 | 59 years STANDARD_DEVIATION 13 |
| Full Mouth Bleeding on Probing (FMBoP) | 13.3 % STANDARD_DEVIATION 6.2 | 13.7 % STANDARD_DEVIATION 6 | 14.2 % STANDARD_DEVIATION 6 |
| Full Mouth Plaque Index (FMPI) | 15.9 % STANDARD_DEVIATION 5.5 | 17.3 % STANDARD_DEVIATION 4.9 | 18.7 % STANDARD_DEVIATION 3.8 |
| Region of Enrollment Switzerland center Bern/Switzerland | 7 Participants | 14 Participants | 7 Participants |
| Region of Enrollment Switzerland center Geneva/Switzerland | 5 Participants | 10 Participants | 5 Participants |
| Region of Enrollment Switzerland center Langenthal/Switzerland | 6 Participants | 13 Participants | 7 Participants |
| Region of Enrollment Switzerland center Lausanne/Switzerland | 3 Participants | 6 Participants | 3 Participants |
| Sex: Female, Male Female | 13 Participants | 24 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 19 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 1 / 21 |
| other Total, other adverse events | 10 / 22 | 9 / 21 |
| serious Total, serious adverse events | 1 / 22 | 2 / 21 |
Outcome results
Primary
Sulcus Bleeding Index (According to Mombelli et al 1987)
The primary endpoint is the difference of Sulcus Bleeding Index (according to Mombelli et al 1987) between baseline (final loading) and 12 months. The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
Time frame: 12 months
Population: per protocol analysis
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | confluent bleeding -> isolated bleeding | 1 sites on teeth |
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | isolated bleeding --> no bleeding | 5 sites on teeth |
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | isolated bleeding --> isolated bleeding | 2 sites on teeth |
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | no bleeding -> no bleeding | 51 sites on teeth |
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | no bleeding -> isolated bleeding | 16 sites on teeth |
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | no bleeding -> confluent bleeding | 1 sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | no bleeding -> isolated bleeding | 14 sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | confluent bleeding -> isolated bleeding | 0 sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | no bleeding -> no bleeding | 53 sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | isolated bleeding --> no bleeding | 9 sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | no bleeding -> confluent bleeding | 1 sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | isolated bleeding --> isolated bleeding | 3 sites on teeth |
Secondary
Adverse Events
All subjects are monitored continuously for adverse event.
Time frame: up to 3 years
Population: ITT Analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Adverse Events | 11 Participants |
| Standard Plus STL Implant | Adverse Events | 11 Participants |
Secondary
Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements
Periapical radiographs are used to measure changes in mesial and distal bone crest levels (of the implant) from baseline (final loading) to one (1) year and three (3) years, respectively. The parameter derives from the subtraction of mesial and distal bone level linear x-ray measurements. The distance between the alveolar bone at the level of the first radiographic bone contact with the implant surface, and the shoulder of the implant will be measured to the closest 0.1mm at the mesial and distal surfaces of all implants on digitized standardized periapical x-rays using an image analysis computer programme. Bone levels are averaged over mesial+distal measurements. Since bone levels were measured from the implant shoulder, an increase in bone level over time corresponds to bone loss.
Time frame: 1 and 3 years
Population: Per-Protocol Analysis. Missing data of some of the patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements | Bone level change from 1 year to baseline | 0.24 mm | Standard Deviation 0.59 |
| Standard Plus ESTA STL Roxolid Implant | Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements | Bone level change from 3 years to baseline | 0.33 mm | Standard Deviation 0.69 |
| Standard Plus STL Implant | Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements | Bone level change from 3 years to baseline | 0.12 mm | Standard Deviation 0.3 |
| Standard Plus STL Implant | Bone Crest Levels. Bone Levels (mm) - Average Over Mesial+Distal Measurements | Bone level change from 1 year to baseline | 0.14 mm | Standard Deviation 0.3 |
Secondary
Clinical Attachment Level (CAL)
The CAL will be measured from the crown margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Clinical attachment level (mm) - average over buccal, palatal, distal and mesial measurements
Time frame: 6 months, 1 and 3 years
Population: Per-Protocol Analysis. Missing data of some of the patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Clinical Attachment Level (CAL) | CAL average, 6 months | 1.9 mm | Standard Deviation 0.5 |
| Standard Plus ESTA STL Roxolid Implant | Clinical Attachment Level (CAL) | CAL average, 1 year | 2.0 mm | Standard Deviation 0.7 |
| Standard Plus ESTA STL Roxolid Implant | Clinical Attachment Level (CAL) | CAL average, 3 years | 1.9 mm | Standard Deviation 0.7 |
| Standard Plus STL Implant | Clinical Attachment Level (CAL) | CAL average, 6 months | 1.8 mm | Standard Deviation 0.7 |
| Standard Plus STL Implant | Clinical Attachment Level (CAL) | CAL average, 1 year | 2.1 mm | Standard Deviation 0.7 |
| Standard Plus STL Implant | Clinical Attachment Level (CAL) | CAL average, 3 years | 2.1 mm | Standard Deviation 0.7 |
Secondary
Dental Implant Success and Implant Loss
The implant success will be defined according to Buser et al 1990. Overall evaluation of implant success.
Time frame: 3 years
Population: Intention to Treat (ITT) Analysis
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Dental Implant Success and Implant Loss | Successful after 3 years | 19 Participants |
| Standard Plus ESTA STL Roxolid Implant | Dental Implant Success and Implant Loss | Patient with implant loss, 3 years | 1 Participants |
| Standard Plus STL Implant | Dental Implant Success and Implant Loss | Patient with implant loss, 3 years | 0 Participants |
| Standard Plus STL Implant | Dental Implant Success and Implant Loss | Successful after 3 years | 18 Participants |
Secondary
Oral Hygiene
Full mouth plaque index (FMPI) and full mouth bleeding on probing index (FMBoP) will be recorded as an indicator for the Oral Hygiene. The indexes are given in percent \[%\] calculated as the total numbers of surfaces with plaque or bleeding divided by the total number of teeth surfaces x100.
Time frame: Screening, 6, 12, 36 months
Population: Per-protocol analysis. Missing data on some patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMBoP, screening | 14 percentage of surfaces | Standard Deviation 6 |
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMBoP, 6 Months | 13 percentage of surfaces | Standard Deviation 6 |
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMBoP, 1 year | 14 percentage of surfaces | Standard Deviation 5 |
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMBoP, 3 years | 16 percentage of surfaces | Standard Deviation 8 |
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMPI, screening | 19 percentage of surfaces | Standard Deviation 4 |
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMPI, 6 Months | 14 percentage of surfaces | Standard Deviation 6 |
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMPI, 1 year | 16 percentage of surfaces | Standard Deviation 5 |
| Standard Plus ESTA STL Roxolid Implant | Oral Hygiene | FMPI, 3 years | 17 percentage of surfaces | Standard Deviation 8 |
| Standard Plus STL Implant | Oral Hygiene | FMPI, 3 years | 18 percentage of surfaces | Standard Deviation 8 |
| Standard Plus STL Implant | Oral Hygiene | FMBoP, screening | 15 percentage of surfaces | Standard Deviation 6 |
| Standard Plus STL Implant | Oral Hygiene | FMPI, screening | 16 percentage of surfaces | Standard Deviation 6 |
| Standard Plus STL Implant | Oral Hygiene | FMBoP, 6 Months | 11 percentage of surfaces | Standard Deviation 6 |
| Standard Plus STL Implant | Oral Hygiene | FMPI, 1 year | 14 percentage of surfaces | Standard Deviation 4 |
| Standard Plus STL Implant | Oral Hygiene | FMBoP, 1 year | 11 percentage of surfaces | Standard Deviation 5 |
| Standard Plus STL Implant | Oral Hygiene | FMPI, 6 Months | 14 percentage of surfaces | Standard Deviation 6 |
| Standard Plus STL Implant | Oral Hygiene | FMBoP, 3 years | 15 percentage of surfaces | Standard Deviation 7 |
Secondary
Probing Pocket Depth (PPD)
The PPD will be measured from the mucosal margin to the bottom of the periimplant pocket by means of an UNC 15 probe. Probing pocket depth (mm) - average over buccal, palatal, distal and mesial measurements.
Time frame: 6 months, 1 and 3 years
Population: Per-Protocol Analysis. Missing data of some of the patients
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Probing Pocket Depth (PPD) | PPD average, 6 Months | 3.0 mm | Standard Deviation 0.5 |
| Standard Plus ESTA STL Roxolid Implant | Probing Pocket Depth (PPD) | PPD average, 1 year | 3.1 mm | Standard Deviation 0.6 |
| Standard Plus ESTA STL Roxolid Implant | Probing Pocket Depth (PPD) | PPD average, 3 years | 3.2 mm | Standard Deviation 0.8 |
| Standard Plus STL Implant | Probing Pocket Depth (PPD) | PPD average, 6 Months | 2.8 mm | Standard Deviation 0.4 |
| Standard Plus STL Implant | Probing Pocket Depth (PPD) | PPD average, 1 year | 2.9 mm | Standard Deviation 0.6 |
| Standard Plus STL Implant | Probing Pocket Depth (PPD) | PPD average, 3 years | 3.0 mm | Standard Deviation 0.6 |
Secondary
Recession of Gingival Margin Buccally and Lingually/Palatal
The recession of the gingival margin will be measured (distance from the gingival margin to the crown/implant margin) by using an UNC 15 periodontal probe. Changes in (averaged) recession at the follow-up visits 12+36 months compared to baseline visit ( final loading ) are displayed
Time frame: 1 and 3 years
Population: Per protocol Analysis. Missing data of some patients.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Recession of Gingival Margin Buccally and Lingually/Palatal | Difference in recession 1 yr to final loading | -0.5 mm | Standard Deviation 0.9 |
| Standard Plus ESTA STL Roxolid Implant | Recession of Gingival Margin Buccally and Lingually/Palatal | Difference in recession 3 yr to final loading | -0.5 mm | Standard Deviation 1.1 |
| Standard Plus STL Implant | Recession of Gingival Margin Buccally and Lingually/Palatal | Difference in recession 1 yr to final loading | -0.6 mm | Standard Deviation 1.1 |
| Standard Plus STL Implant | Recession of Gingival Margin Buccally and Lingually/Palatal | Difference in recession 3 yr to final loading | -0.7 mm | Standard Deviation 1.1 |
Secondary
Soft Tissue Healing Evaluation
Assessment of the wound healing by classifying the implantation site (normal or compromised healing).
Time frame: 10 days and 12 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Soft Tissue Healing Evaluation | normal healing, 10 days | 22 participants |
| Standard Plus ESTA STL Roxolid Implant | Soft Tissue Healing Evaluation | normal healing, 12 weeks | 22 participants |
| Standard Plus STL Implant | Soft Tissue Healing Evaluation | normal healing, 10 days | 21 participants |
| Standard Plus STL Implant | Soft Tissue Healing Evaluation | normal healing, 12 weeks | 21 participants |
Secondary
Sulcus Bleeding Index (According to Mombelli et al 1987)
The inflammatory status of the mucosa will be evaluated by means of a UNC 15 periodontal probe. 0: No bleeding when a periodontal probe is passed along the peri-implant sulcus 1. Isolated bleeding spots are recognizable 2. Confluent bleeding line along the marginal mucosa 3. Profound bleeding.
Time frame: 3 years
Population: Per-Protocol Analysis
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | No Bleeding | 59 Sites on teeth |
| Standard Plus ESTA STL Roxolid Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | Bleeding | 17 Sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | No Bleeding | 60 Sites on teeth |
| Standard Plus STL Implant | Sulcus Bleeding Index (According to Mombelli et al 1987) | Bleeding | 16 Sites on teeth |