Dental ImplantsNCT02836964
Early Loading of Dental Implants: A Prospective Study in the Mandibular First Molar Area
An observational study of Dental Implants, run by Loma Linda University at 1 site in United States.
Trial summary
This study will compare tissue healing outcome between early dental implant loading at 4 weeks and conventional dental implant loading at 3 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implants
- What is being tested?
- Crown placement
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2017to Sep 2018
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Dental patients who are seen at the LLU Department of Implant Dentistry
Who may be able to join
- Patients aged 18 years or older.
- Willingness to comply with all study requirements.
- Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
- Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
- Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
- Sufficient alveolar bone volume at the implant recipient site at the time of the insertion.
- Adequate oral hygiene. Full-mouth plaque score (FMPS) (O'Leary et al. 1972) full-mouth bleeding score (FMBS) (Ainamo \& Bay 1975) record as the percentage of surfaces, four per each tooth, patients need to have controlled their periodontal conditions (FMPS 20%, FMBS 20%).
Who cannot join
- Pregnant or lactating females.
- Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
- History of irradiation in the head and neck area.
- Smoking.
- Untreated periodontitis.
- Alcohol or drug abuse.
Show all 13Show fewer
- History of Intravenous Bisphosphonate.
- Previously augmented or tooth extraction at the intended implant recipient site within the last 6 months.
- The use of regenerative procedures in conjunction with implant placement.
- Presence of residual roots at the implant recipient site.
- Stomatological diseases.
- Clinical signs of bruxism.
- Initial stability at least 30Ncm
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University, Center for Implant Dentistry
Loma Linda, California, 92350
About this study
Official title: Early Loading of Dental Implants: A Prospective Study in the Mandibular First
This study will compare tissue healing outcome between early dental implant loading at 4 weeks and conventional dental implant loading at 3 months.
Read the detailed description
Both loading times are standard of care procedures. The rationale behind early loading is to reduce waiting time so dental implants can be utilized sooner.
- Conditions
- Dental Implants
- Being tested
- Crown placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crown placementDevice
Dental implant
| Study group | Role | What they receive |
|---|---|---|
| Group A Early Loading | Crown placement will occur at 4 weeks post implant Receives: Device: Crown placement | |
| Group B Conventional Loading | Crown placement will occur at 3 months post implant Receives: Device: Crown placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of marginal bone level changes
Standardized intraoral radiograph will be used to measure the distance between the implant platform and the marginal bone
Measured: Change between Implant Placement Visit and Final evaluation Visit at 6 months post dental implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startFeb 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionSep 2018 (estimated)
Why it stopped: The protocol was completely changed by the resident's guidance committee and the protocol associated with this IRB approval number was never enacted.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantsStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aladdin Alardah, DDS, MS, Principal investigator, associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836964
- Sponsor's protocol ID
- 5160039
- Status last verified
- Oct 2024
- First submitted
- 15 Jul 2016
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Loading of Dental Implants: A Prospective Study in the Mandibular First
- ClinicalTrials.gov ID
- NCT02836964
- Acronym / sponsor ID
- 5160039
- Conditions
- Dental Implants
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The protocol was completely changed by the resident's guidance committee and the protocol associated with this IRB approval number was never enacted.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 19 Jul 2016 (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.
This study will compare tissue healing outcome between early dental implant loading at 4 weeks and conventional dental implant loading at 3 months.
Detailed description
Both loading times are standard of care procedures. The rationale behind early loading is to reduce waiting time so dental implants can be utilized sooner.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A Early Loading | – | Device: Crown placementCrown placement will occur at 4 weeks post implant |
| Group B Conventional Loading | – | Device: Crown placementCrown placement will occur at 3 months post implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Dental patients who are seen at the LLU Department of Implant Dentistry
Key inclusion criteria (7 listed)
- Patients aged 18 years or older.
- Willingness to comply with all study requirements.
- Partially edentulous in the in mandibular first molar with presence of the mandibular second molar
- Patients of ASA I and ASA II group. No relevant medical conditions such as uncontrolled diabetes mellitus, osteoporosis, malignancies, irradiation and blood dyscrasias.
- Free from soft tissue mucosal lesions, caries, and active periodontitis at the time of implant insertion.
Key exclusion criteria (13 listed)
- Pregnant or lactating females.
- Systemic disease likely to compromise implant surgery; uncontrolled diabetes mellitus.
- History of irradiation in the head and neck area.
- Smoking.
- Untreated periodontitis.
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 |
|---|---|---|
| Crown placementDental implant | Device | Group A Early Loading, Group B Conventional Loading |
Primary outcome
Assessment of marginal bone level changes
Time frame: Change between Implant Placement Visit and Final evaluation Visit at 6 months post dental implant
Standardized intraoral radiograph will be used to measure the distance between the implant platform and the marginal bone
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Dental Implants
Not yet recruiting
Free Soft Tissue Grafts (FSTG) Using Autograft Palatal Donor Tissue vs. Xenograft Collagen Matrix (Zderm™)
Gingival Recession Localized Moderate, Dental Implant
Not yet recruiting
Safety Assessment of Placing a Single Dental Implant Without Antibiotic Prophylaxis in Simple Cases: A Pilot Study
Tooth Loss and Rehabillitation, Dental Implant Failure
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Clinical and Radiographic Evaluation of Dentsply Sirona PrimeTaper Implants
Dental Implants
Active, not recruiting
The Aim of the Study Will be Clinically and Radio Graphically Comparison of Two Implant Designs Used to Treat Atrophied Mandible . Implant Design Comparison Will Done for Implant Stability,Peri-implant Soft Tissue Health Changes and Bone Changes .Patients Will be Divided Randomly Into Two Group
Dental Implant Bone Loss, Peri-Implant Health
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.
Aladdin Alardah, DDS, MS principal investigator
associate professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants, run by Loma Linda University 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 7 inclusion and 13 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: withdrawn, as of the sponsor's last update on 18 Oct 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assessment of marginal bone level changes (time frame: Change between Implant Placement Visit and Final evaluation Visit at 6 months post dental implant). 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 18 Oct 2024.