Jaw, Edentulous, PartiallyNCT02154581
Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone
A study testing SLActive implant in people with Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction. The investigators want to observe how the gums change shape with healing in two different scenarios: 1. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Jaw, Edentulous, Partially, Acquired Absence of Single Tooth
- What is being tested?
- SLActive implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to 28 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient is 18 years or older.
- Ability to understand and provide informed consent before starting the study.
- Ability and willingness to comply with all study requirements.
- The patient, if of child-bearing potential, has a negative urine pregnancy test.
- Adequate oral hygiene to allow for implant therapy consistent with standards of care.
- Adequate bone volume to accommodate the planned endosseous dental implant placement according to immediate placement protocols utilizing Straumann Bone Level implants RC (Regular Crossfit) 4.1mm or Bone Level Implant NC (Narrow Crossfit) 3.3 mm at 8, 10,12 or 14mm in length.
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- One tooth in the anterior maxilla (first pre-molar to first pre-molar) requiring extraction resulting in a single- tooth gap planned to be restored with a dental implant as determined by the patient's dental provider.
- The site to be treated is surrounded by two natural teeth.
- Except the site to be treated, none of the maxillary incisors, canines and first pre-molars display marginal soft tissue recession.
- Following extraction, intact extraction socket bony walls are present.
- Primary stability of implant consistent with standards of care is achieved at the time of implant placement.
- Patient must be able to pay for fees related to the surgical implant placement related to extraction, grafting of the implant site, and half of the cost of the crown at the time of implant placement.
Who cannot join
- Patient reports tobacco use within the last five years. Tobacco use for this study is defined as a current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or tobacco chewing use.
- History of alcoholism or drug abuse within the past 5 years.
- Severe wear with an etiology of bruxism or clenching habits.
- Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
- History of HIV infection, Hepatitis B or C.
- Patients with a history of systemic disease that precludes standard dental implant therapy or alters daily activities to a level consistent with ASA (American Society of Anesthesiologists) III classification (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders).
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- Presence of local inflammation or mucosal diseases such as lichen planus.
- Patient history consistent with high risk for subacute bacterial endocarditis.
- Current hematological disorder or warfarin (or similar) therapy.
- Patient has a disease that affects bone metabolism, such as, but not limited to, osteoporosis, hyperthyroidism, hyperparathyroidism, congenital connective tissue disorders (e.g., osteogenesis imperfecta), or Paget's disease.
- Patient is taking medications or having treatments known to have an effect on bone turnover, including: thiazide diuretics, calcitonin, systemic steroids, bisphosphonates, vitamin D (>800 IU/day), estrogen or progesterone therapy.
- Current steroid treatment: defined as any person who within the last two years has received for two weeks a dose equivalent to 20 mg hydrocortisone.
- Patient currently undergoing chemotherapy.
- Patient history of radiation treatment to the head or neck.
- Physical or mental handicaps that would interfere with patient's ability to exercise good oral hygiene on a regular basis.
- Use of any investigational drug or device within the 30 day period immediately prior to implant surgery.
- Patient is pregnant.
- Extraction sites having anatomic conditions that preclude immediate implant placement.
Trial locations and contacts
1 site in 1 country.
United States1 site
Graduate Periodontics, Dental School, UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone: A Controlled Clinical Trial
In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction. The investigators want to observe how the gums change shape with healing in two different scenarios:
- If the soft tissue around your tooth is thin, following extraction and implant placement an extra soft tissue graft (taken from your palate) in the area in order to increase the thickness of your gums after healing.
- If the soft tissue around your tooth is thick, the implant will be placed without a soft tissue graft.
Read more
Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely but they have never been compared objectively to one another in the same research study.
The main purpose of this study is to evaluate if there is any difference in terms of esthetic outcomes between these two treatment modalities after a crown has been placed on the implant.
- Being tested
- SLActive implant
- Keywords
- Dental implants, Esthetic score, Immediate implants, Gingival biotype
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLActive implantDevice
Also called Straumann, Dental Implants, Type 1 implant placement
| Study group | Role | What they receive |
|---|---|---|
| Type 1 implant and thin biotype | Active comparator | In this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed. Receives: Device: SLActive implant |
| Type 1 implant and thick biotype | Active comparator | In this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket. Receives: Device: SLActive implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid Facial Mucosal Level at Implant Site
Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.
Measured: Change from Baseline to 3 months
Secondary outcomes (5)
PES/WES (Pink Esthetic Score, White Esthetic Score).
Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 12 months after crown delivery. The PES (Pink Esthetic Score) and WES (White Esthetic Score) scales are 10 point scales, made up of 5 categories, each with a 2 point value. Each category is scored out of 2, and the scores totaled to give an optimal score out of 10, and then the two scores (PES and WES) added to give a total score out of 20, with 20 being the highest possible score (best outcome) and 0 being the worst outcome.
Measured: Approximately 1 year after baseline
Probing Depth
Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline, 3 and 12 months after crown delivery. The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3 mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.
Measured: Up to 1 year after baseline
Modified Plaque Index
Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Measurement of amount of plaque build-up on teeth, using a scale of 0 (no plaque detection), to 3 (an abundance of soft matter). The scores are totaled and a mean score reported.
Measured: Up to 1 year after baseline
Modified Bleeding Index
Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at 3, 6, 12 months after crown delivery. Bleeding from the gums is measured on probing the gum and measured on scale of 0 to 5, with 0 being the best outcome, with no bleeding, and 5 being the worst outcome, with spontaneous bleeding. The scores are totaled and a mean score reported.
Measured: Up to 1 year after baseline
Radiographic Bone Level
Baseline will be at the time of crown delivery. Secondary outcome measures will be recorded at baseline 3, and 12 months after crown delivery. Radiographic bone measurements recorded following final restoration placement (baseline), after 3 and 12 months of loading, and change between these time points. A positive value indicates bone loss and a negative value indicates bone gain. BIC (Bone implant contact)= Distance from implant shoulder to first bone to implant contact.
Measured: Up to 1 year after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2014 (estimated)
- Study startJan 2013
- Primary completion28 Apr 2018
- Study completion28 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Jaw, Edentulous, PartiallyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Responsible party
- Sponsor
- Investigators
- Guy Huynh-Ba, DDS, MS, Principal investigator, UTHSCSA Department of Periodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02154581
- Sponsor's protocol ID
- ITI 799_2011
- Other IDs
- HSC20130085H
- Status last verified
- Jun 2019
- First submitted
- 30 May 2014
- Last updated
- 9 Jul 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Case Selection and Treatment Protocol for Immediate Dental Implants in the Esthetic Zone: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02154581
- Acronym / sponsor ID
- ITI 799_2011
- Keywords
- Dental implants, Esthetic score, Immediate implants, Gingival biotype
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Collaborators
- ITI International Team for Implantology, Switzerland
- Study start
- Jan 2013
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 28 Apr 2018 (actual)
- First posted
- 3 Jun 2014 (estimated)
- Results
- Posted 9 Jul 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study a tooth that needs to be extracted will be replaced by an implant (artificial root) placed at the same appointment as the extraction. The investigators want to observe how the gums change shape with healing in two different scenarios:
- If the soft tissue around your tooth is thin, following extraction and implant placement an extra soft tissue graft (taken from your palate) in the area in order to increase the thickness of your gums after healing.
- If the soft tissue around your tooth is thick, the implant will be placed without a soft tissue graft.
Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely but they have never been compared objectively to one another in the same research study.
The main purpose of this study is to evaluate if there is any difference in terms of esthetic outcomes between these two treatment modalities after a crown has been placed on the implant.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type 1 implant and thin biotype | Active comparator | Device: SLActive implantIn this group, immediate implant placement (SLActive implant) is performed in patients with thin tissue biotype. In addition to implant placement bone grafting of the void between the implant and the fresh extraction socket, bone grafting the buccal aspect of the buccal plate (overcontouring) and soft tissue grafting (connective tissue) are performed. |
| Type 1 implant and thick biotype | Active comparator | Device: SLActive implantIn this group, immediate implant placement (SLActive implant) is performed including bone grafting of the void between the implant and the fresh extraction socket. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- The patient is 18 years or older.
- Ability to understand and provide informed consent before starting the study.
- Ability and willingness to comply with all study requirements.
- The patient, if of child-bearing potential, has a negative urine pregnancy test.
- Adequate oral hygiene to allow for implant therapy consistent with standards of care.
Key exclusion criteria (18 listed)
- Patient reports tobacco use within the last five years. Tobacco use for this study is defined as a current smoking habit with moderate or heavy smoking (more than 10 cigarettes per day) or tobacco chewing use.
- History of alcoholism or drug abuse within the past 5 years.
- Severe wear with an etiology of bruxism or clenching habits.
- Patient has significant untreated periodontal disease (grade III or IV), caries, or clinical or radiographic signs of infection within two adjacent tooth positions of implant area.
- History of HIV infection, Hepatitis B or C.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLActive implantAlso: Straumann, Dental Implants, Type 1 implant placement | Device | Type 1 implant and thick biotype, Type 1 implant and thin biotype |
Primary outcome
Mid Facial Mucosal Level at Implant Site
Time frame: Change from Baseline to 3 months
Baseline will be at the time of crown delivery. Thereafter, the mid facial mucosal level at implant site will be recorded at 3, 6, 12 months after crown delivery.
5 secondary outcomes
PES/WES (Pink Esthetic Score, White Esthetic Score).
Time frame: Approximately 1 year after baseline
Probing Depth
Time frame: Up to 1 year after baseline
Modified Plaque Index
Time frame: Up to 1 year after baseline
Modified Bleeding Index
Time frame: Up to 1 year after baseline
Radiographic Bone Level
Time frame: Up to 1 year after baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guy Huynh-Ba, DDS, MS principal investigator
UTHSCSA Department of Periodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SLActive implant in people with Jaw, Edentulous, Partially and Acquired Absence of Single Tooth, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid Facial Mucosal Level at Implant Site (time frame: Change from Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2019; AzTrials last refreshed its copy on 29 Oct 2026.