Facial Gingival ProfileNCT01547273
The Effect of Bone Grafts on Facial Gingival Profile in Maxillary Anterior Single Tooth Replacement
A study testing bone graft inside socket only, bone graft inside and outside socket and no bone graft in people with Facial Gingival Profile, run by Loma Linda University at 2 sites in United States.
Trial summary
The purpose of this investigator-initiated study is to evaluate the facial gingival profile following immediate implant placement and provisionalization in conjunction with connective tissue graft with or without bone graft Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Facial Gingival Profile
- What is being tested?
- bone graft inside socket only, bone graft inside and outside socket and no bone graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Mar 2012to 7 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients must be 18 years of age or older, are no longer growing and able to read and sign an informed consent.
- Good oral hygiene.
- A single failing maxillary anterior tooth (#6-11) with the presence of healthy adjacent teeth.
- Adequate bone volume to accommodate an implant with minimum dimensions of 3.6 mm diameter and 10.0 mm length.
- Presence of opposing dentition (natural teeth, fixed or removable prostheses)
- Healthy soft tissue at the future implant site.
Who cannot join
- A medical history that would complicate the outcome of study such as alcohol or drug dependency, poor health ,uncontrolled diabetes, immunodeficiency diseases, taking any medication that may cause gingival over growth or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and required follow-up examinations.
- Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion
- Smoker.
- History of head and neck radiation.
- Soft tissue defect (inflammation, tissue cleft, unhealthy tissue) around a future implant site.
- Inability to achieve primary implant stability following immediate implant placement.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Implant Department, School of dentistry, Loma Linda University
Loma Linda, California, 92350
Loma Linda University School of Dentistry
Loma Linda, California, 92350
About this study
Official title: The Effect of Bone and Connective Tissue Grafts on Facial Gingival Profile in Single Maxillary Anterior Immediate Implant Placement and Provisionalization: A 1-Year Prospective Study
The purpose of this investigator-initiated study is to evaluate the facial gingival profile following immediate implant placement and provisionalization in conjunction with connective tissue graft with or without bone graft
Read the detailed description
Thirty subjects who are at least 18 years old with a failing upper front tooth seeking for implant treatment will be recruited at Loma Linda University School of Dentistry (LLUSD), where the consent will also take place. The subjects will be randomly divided into 3 groups. The subjects will receive immediate implant placement and provisionalization (IIPP) in conjunction with connective tissue graft (CTG) with (Group I) or without (Group II) bone graft in the extraction socket; and with bone graft in extraction socket and at the facial aspect of failing tooth (Group III). Clinical, radiographic and model assessments will be performed at different time intervals (pre-treatment to 12 months after implant placement) and statistically analyzed (α = 0.05) to evaluate peri-implant tissue response and facial gingival profile of the implants. Complications, if any, will also be recorded and appropriately addressed.
- Conditions
- Facial Gingival Profile
- Being tested
- bone graft inside socket only, bone graft inside and outside socket, no bone graft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bone graft inside socket onlyProcedure or surgery
bone graft inside socket only
bone graft inside and outside socketProcedure or surgery
bone graft inside and outside socket
no bone graftProcedure or surgery
no bone graft
| Study group | Role | What they receive |
|---|---|---|
| bone graft inside socket only | Experimental | bone graft inside socket only Receives: Procedure: bone graft inside socket only |
| bone graft inside and outside socket | Experimental | bone graft inside and outside socket Receives: Procedure: bone graft inside and outside socket |
| no bone graft | Experimental | no bone graft Receives: Procedure: no bone graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in facial gingival profile
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2012 (estimated)
- Study start20 Mar 2012
- Primary completion7 Apr 2016
- Study completion7 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Gingival ProfileStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- DentiumUSA
- Responsible party
- Sponsor
- Investigators
- Joseph YK Kan, DDS, MS, Principal investigator, Loma Linda University School of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01547273
- Sponsor's protocol ID
- 5110339
- Status last verified
- Apr 2021
- First submitted
- 12 Jan 2012
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bone and Connective Tissue Grafts on Facial Gingival Profile in Single Maxillary Anterior Immediate Implant Placement and Provisionalization: A 1-Year Prospective Study
- ClinicalTrials.gov ID
- NCT01547273
- Acronym / sponsor ID
- 5110339
- Conditions
- Facial Gingival Profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- DentiumUSA
- Study start
- 20 Mar 2012 (actual)
- Primary completion
- 7 Apr 2016 (actual)
- Study completion
- 7 Apr 2016 (actual)
- First posted
- 7 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigator-initiated study is to evaluate the facial gingival profile following immediate implant placement and provisionalization in conjunction with connective tissue graft with or without bone graft
Detailed description
Thirty subjects who are at least 18 years old with a failing upper front tooth seeking for implant treatment will be recruited at Loma Linda University School of Dentistry (LLUSD), where the consent will also take place. The subjects will be randomly divided into 3 groups. The subjects will receive immediate implant placement and provisionalization (IIPP) in conjunction with connective tissue graft (CTG) with (Group I) or without (Group II) bone graft in the extraction socket; and with bone graft in extraction socket and at the facial aspect of failing tooth (Group III). Clinical, radiographic and model assessments will be performed at different time intervals (pre-treatment to 12 months after implant placement) and statistically analyzed (α = 0.05) to evaluate peri-implant tissue response and facial gingival profile of the implants. Complications, if any, will also be recorded and appropriately addressed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bone graft inside socket only | Experimental | Procedure: bone graft inside socket onlybone graft inside socket only |
| bone graft inside and outside socket | Experimental | Procedure: bone graft inside and outside socketbone graft inside and outside socket |
| no bone graft | Experimental | Procedure: no bone graftno bone graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients must be 18 years of age or older, are no longer growing and able to read and sign an informed consent.
- Good oral hygiene.
- A single failing maxillary anterior tooth (#6-11) with the presence of healthy adjacent teeth.
- Adequate bone volume to accommodate an implant with minimum dimensions of 3.6 mm diameter and 10.0 mm length.
- Presence of opposing dentition (natural teeth, fixed or removable prostheses)
Key exclusion criteria (6 listed)
- A medical history that would complicate the outcome of study such as alcohol or drug dependency, poor health ,uncontrolled diabetes, immunodeficiency diseases, taking any medication that may cause gingival over growth or any other medical, physical or psychological reason that might affect the surgical procedure or the subsequent prosthodontic treatment and required follow-up examinations.
- Dental history of bruxism, parafunction habit, and/or lack of stable posterior occlusion
- Smoker.
- History of head and neck radiation.
- Soft tissue defect (inflammation, tissue cleft, unhealthy tissue) around a future implant site.
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 |
|---|---|---|
| bone graft inside socket onlybone graft inside socket only | Procedure or surgery | bone graft inside socket only |
| bone graft inside and outside socketbone graft inside and outside socket | Procedure or surgery | bone graft inside and outside socket |
| no bone graftno bone graft | Procedure or surgery | no bone graft |
Primary outcome
change in facial gingival profile
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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.
Joseph YK Kan, DDS, MS principal investigator
Loma Linda University School of Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bone graft inside socket only, bone graft inside and outside socket and no bone graft in people with Facial Gingival Profile, run by Loma Linda University at 2 sites 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 6 inclusion and 6 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 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
change in facial gingival profile (time frame: 1 year). 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 26 Apr 2021.