NCT01623739

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 20, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

October 20, 2017

Completed
Last Updated

September 25, 2018

Status Verified

October 1, 2017

Enrollment Period

5.4 years

First QC Date

April 26, 2012

Results QC Date

May 31, 2017

Last Update Submit

September 24, 2018

Conditions

Jaw, Edentulous, PartiallyAcquired Absence of Single Tooth

Keywords

Dental implantsEsthetic scoreImmediate implantsEarly placement

Outcome Measures

Primary Outcomes (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.

    3 months after crown delivery

Secondary Outcomes (5)

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

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

  • Probing Depth

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

  • Modified Plaque Index

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

  • Modified Bleeding Index

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

  • Radiographic Bone Level

    Up to 5 years after baseline

Study Arms (2)

Type 1 implant placement

ACTIVE COMPARATOR

Placement of a dental implant: Implant is placed immediately following tooth extraction in one surgical procedure

Procedure: Placement of a dental implant

Type 2 implant placement

ACTIVE COMPARATOR

Placement 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.

Procedure: Placement of a dental implant

Interventions

Placement of a dental implantPROCEDURE

Type 1 implant placement Type 2 implant placement

Also known as: Straumann, SLActive, Dental Implants
Type 1 implant placementType 2 implant placement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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).
  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Graduate Periodontics, Dental School, UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Interventions

Dental Implants

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Intervention Hierarchy (Ancestors)

Dental MaterialsBiomedical and Dental MaterialsDental ProsthesisProsthodonticsDentistryProstheses and ImplantsEquipment and SuppliesManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
Guy Huynh-Ba
Organization
UTHSCSA Periodontics
huynhba@uthscsa.edu
2105673569

Study Officials

  • Guy Huynh-Ba, DDS, MS

    UTHSCSA Department of Periodontics

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2012

First Posted

June 20, 2012

Study Start

December 1, 2010

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

September 25, 2018

Results First Posted

October 20, 2017

Record last verified: 2017-10

Locations

US(1)