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Jaw, Edentulous, PartiallyNCT01623739

Esthetic, Clinical and Radiographic Outcomes of Immediately Placed Implants (Type 1) and Early Placed Implants (Type 2)

A study testing Placement of a dental 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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators are asking subjects to take part in a research study of soft tissue (gums) and bone (jawbone) healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes 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
What is being tested?
Placement of a dental implant
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteUnited States
Study dates
Dec 2010to May 2016
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 following immediate placement protocols utilizing Straumann Bone Level implants RC 4.1mm or Bone Level Implant NC 3.3 mm at 8, 10, 12 or 14 mm in length.
Show all 9Show fewer
  • One or more teeth in either the maxilla or mandible anterior or premolar areas requiring extraction leading to a single-tooth gap requiring implant placement as determined by the patient's dental provider.
  • Following extraction, surgical site anatomy presents conditions allowing immediate implant placement.
  • Primary stability of implant consistent with standards of care is achieved at the time of placement.

Who cannot join

  • Patient reports 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 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 III classification (including cardiovascular, hepatic, renal, gastrointestinal, metabolic, neurologic, pulmonary, endocrine, autoimmune, or psychiatric disorders).
Show all 18Show fewer
  • 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 coumadin (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

Other trials in United States

About this study

The investigators are asking subjects to take part in a research study of soft tissue (gums) and bone (jawbone) healing around dental implants following tooth extraction. The investigators want to compare how the gums and the bone changes shape with healing in two different scenarios:

  1. When the implant is placed at the same time the tooth is extracted.
  2. When the tooth is extracted and then left to heal for a period of 4 to 8 weeks before the implant is placed.

Previous studies have shown that both methods work and can give good results. In fact the two methods are used routinely as part of standard care but it is not known if the two procedures are equally good since they have never been compared in one same research study.

Read the detailed description

This controlled, randomized clinical trial (RCT) is designed to compare soft and hard tissue dimensional changes for two commonly used approaches for replacing a recently extracted tooth by means of a dental implant, i.e. immediate implant placement (Type 1) or early implant placement (Type 2). Additionally, this study will evaluate the association between the osseous anatomy and implant position with soft and hard tissue changes.

Extraction sites will include maxillary and mandibular anterior and premolar teeth having intact adjacent teeth. Implants placed for this study will be SLA surface, bone level design, Straumann BL RC (Bone Level Regular Cross-fit ) 4.1mm or BL NC (Bone Level Narrow Cross-fit ) 3.3mm diameter implants at 8, 10, 12 or 14mm in length.

Immediate implant placement (Type 1) resulting in a horizontal defect dimension (HDD) will receive bone grafting, using freeze dried bone allograft (FDBA)(Straumann Allograft GC®) and will be covered by a resorbable membrane (BioGide®).

For the implants randomized to type 2 implant placement, the extraction socket will be filled with a collagen plug and allowed to heal for 4 to 8 weeks before the implant will be placed. Simultaneous guided bone regeneration (GBR) will be performed using FDBA (Straumann Allograft GC®)and a resorbable collagen membrane (BioGide®). The type 2 implant placement procedure will follow the guidelines as described by Buser et al. (2008).

All implant placement will follow standard protocols utilizing tapping and placement according to the manufacturer's guidelines.

Being tested
Placement of a dental implant
Keywords
Dental implants, Esthetic score, Immediate implants, Early placement
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.

  • Placement of a dental implantProcedure or surgery

    Also called Straumann, SLActive, Dental Implants

    Type 1 implant placement Type 2 implant placement

Study groups in NCT01623739
Study groupRoleWhat they receive
Type 1 implant placementActive comparatorPlacement of a dental implant: Implant is placed immediately following tooth extraction in one surgical procedure
Receives: Procedure: Placement of a dental implant
Type 2 implant placementActive comparatorPlacement of a dental implant: Once the tooth is extracted. The site is left to heal for 4 to 8 weeks before a dental implant is placed during a second surgical procedure.
Receives: Procedure: Placement of a dental implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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, 24, 36, 48, 60 months after crown delivery.

    Measured: 3 months after crown delivery

Secondary outcomes (5)

  1. PES/WES (Pink Esthetic Score, White Esthetic Score).

    The PES and WES 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. Any score of 6 or higher out of 10 would be considered a good clinical outcome. the PES categories focus on the gum area, and the WES categories focus on the tooth. The scores for PES and WES are totaled, to give a score out of 20, with 20 being the highest possible score (best outcome). The values are totaled and a mean score of all the readings is reported.

    Measured: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

  2. Probing Depth

    The measurement of the pocket around the implanted tooth, measured with a graduated probe. A healthy pocket depth is around 3mm with no bleeding during the measurement process. The values are totaled and a mean score of all the readings is reported.

    Measured: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

  3. Modified Plaque Index

    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: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

  4. Modified Bleeding Index

    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: 3, 6, 12, 24, 36, 48, 60 months after crown delivery

  5. Radiographic Bone Level

    Secondary outcome measures will be recorded at 3, 6, 12, 24, 36, 48, 60 months after crown delivery.

    Measured: Up to 5 years after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2012 (estimated)
  2. Study startDec 2010
  3. Primary completionMay 2016
  4. Study completionMay 2016

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623739
Sponsor's protocol ID
ITI 689_2010
Status last verified
Oct 2017
First submitted
26 Apr 2012
Last updated
25 Sep 2018
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Placement of a dental 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 9 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 25 Sep 2018. 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 20 Oct 2017). 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: 3 months after crown delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01623739.

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 25 Sep 2018.

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