Immediate vs Delayed Loading of Dental Implants for Implant Complications

Overseen By Elysha Pomerantz, DMD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Case Western Reserve University

Must not be taking: Antibiotics, Steroids, Chemotherapy, others

Disqualifiers: HIV, Alcoholism, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the best method for attaching dentures to dental implants in the upper jaw. Researchers are comparing two approaches: connecting the dentures to implants immediately after surgery (immediate loading of maxillary implant overdenture) or waiting three months (delayed loading of maxillary implant overdenture). They seek to identify which method results in less bone loss around the implants and better overall outcomes. Individuals with a fully toothless upper jaw who currently wear well-fitting dentures might be suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to significant dental research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on medications that require chronic use of antibiotics or prolonged use of steroids, you may not be eligible to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that both immediate and delayed loading of dental implants are generally safe, with no major differences in implant stability. Immediate loading involves attaching dentures to the implants on the same day as surgery. This method can succeed and reduce treatment time. However, some studies suggest a lower chance of long-term implant success and a decrease in bone around the implant compared to the traditional method, where implants heal for a few months before dentures are added. Overall, both methods are well-tolerated and considered safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring two different approaches to loading dental implants, which could significantly impact patient outcomes. Traditionally, dental implants require a healing period before any dentures or bridges are attached, known as delayed loading. But this trial is comparing that method with immediate loading, where dentures are connected to implants on the same day as the surgery. This could mean quicker results for patients and possibly a faster return to normal function and appearance. If successful, immediate loading could revolutionize the way dental implants are managed, offering a more efficient alternative to the current standard of care.

What evidence suggests that this trial's treatments could be effective for implant complications?

This trial will compare the immediate loading of maxillary implant overdentures with the delayed loading approach. Research has shown that attaching dentures to implants in the upper jaw immediately, as in the immediate loading arm of this trial, can be effective. Studies have found that this method often works well and is a reliable treatment. Patients who have undergone this procedure generally report positive experiences. However, some research suggests that implants may not last as long as with traditional methods, such as the delayed loading approach tested in this trial. Even so, the immediate approach still offers promising short-term results. ^{2 5 6 7 8}

Who Is on the Research Team?

Gian P Schincaglia, DDS, PhD

Principal Investigator

Case Western Reserve University

Are You a Good Fit for This Trial?

This trial is for adults over 21 who have no teeth in their upper jaw, are currently using dentures that fit well, and have enough bone for dental implants without needing a bone graft. People with HIV, ongoing infections or inflammation, bleeding or metabolic bone disorders, poor oral hygiene, history of certain cancers or radiation therapy to the jaw can't participate.

Inclusion Criteria

Wearing complete dentures deemed adequate

Your dental implant needs to have a certain level of stability, measured at 20 N/cm or higher.

I have no natural teeth in my upper jaw.

Exclusion Criteria

You do not take good care of your teeth or do not brush them regularly at home.

You cannot have used any experimental drugs or devices in the 30 days before the surgery.

You use e-cigarettes, chew tobacco, or smoke more than 10 cigarettes every day.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Surgical Procedure

Implants are placed using a flapless guided surgery and patients are randomly assigned to immediate or delayed loading groups

1 day

1 visit (in-person)

Immediate Loading

For the test group, the maxillary denture is immediately connected to the implants

12 weeks

Visits at 1, 2, 4, and 12 weeks

Delayed Loading

For the control group, implants are exposed and connected to the prosthesis after 3 months of healing

12 weeks

Visits at 1, 2, 4, and 12 weeks

Follow-up

Participants are monitored for implant survival, peri-implant mucosa condition, and patient-centered outcomes

36 months

Visits at 6, 12, 24, and 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Delayed loading of maxillary implant overdenture
• Immediate loading of maxillary implant overdenture

Trial Overview The study compares two methods of fitting complete dentures on implants in the upper jaw: one where the denture is loaded immediately onto newly placed implants (immediate loading), and another where there's a waiting period before loading the denture (delayed loading). The main focus is on how much bone loss occurs around the implant over three years.

How Is the Trial Designed?

Group I: Test - IL ( Immediate Loading) Experimental Treatment 1 Intervention

The maxillary denture will be immediately connected to the implants on the day of the surgery

Group II: Control - DL ( Delayed Loading) Active Control 1 Intervention

At the time of surgery, the cover screw will be seated on the implants and the flap will be sutured for a submerged healing. After 3 months of healing the implants will be exposed and connected to the prosthesis following the same prosthetic protocol as the test group.

Delayed loading of maxillary implant overdenture is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Delayed loading protocol for:

• Edentulous maxillae
• Maxillary overdenture

Approved in United States as Delayed loading protocol for:

• Edentulous maxillae
• Maxillary overdenture

Approved in Canada as Delayed loading protocol for:

• Edentulous maxillae
• Maxillary overdenture

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

Institut Straumann AG

Industry Sponsor

Trials

54

Recruited

2,700+

Published Research Related to This Trial

A systematic review and meta-analysis of 7 studies involving immediate versus delayed loading of dental implants for mandibular overdentures found no significant differences in prosthetic complications or maintenance outcomes between the two methods.

While delayed loading showed a tendency to have fewer complications, the evidence did not reach statistical significance, suggesting that immediate loading can be a viable option without compromising patient satisfaction or quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcome measures and prosthetic events in implant-supported mandibular overdenture patients after immediate versus delayed loading: A systematic review and meta-analysis. Ribeiro, AKC., Costa, RTF., Vasconcelos, BCDE., et al.[2022]

A systematic review of 7 randomized controlled trials involving 2498 records found that while the implant failure rate was slightly higher for immediate loading of 2-implant mandibular overdentures, the difference was not statistically significant compared to delayed loading.

There was no significant difference in marginal bone loss between immediate and delayed loading protocols, suggesting that both methods may be equally effective in maintaining implant health over at least 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate or delayed loading protocols for two-implant mandibular overdentures: A systematic review and meta-analysis of randomized controlled trials. Cao, ZL., Li, X., Lin, LJ., et al.[2023]

In a study involving 24 edentulous maxilla patients, both immediate and early loading of implants showed similar stability after 6 weeks, indicating that the loading protocol does not significantly affect implant stability.

Patients who received immediate loading reported better oral health-related quality of life and higher satisfaction scores, suggesting that immediate loading may enhance patient experience when using fixed full-arch dentures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate Vs Early Loading of Bone Level Tapered Dental Implants With Hydrophilic Surface in Rehabilitation of Fully Edentulous Maxilla: Clinical and Patient Centered Outcomes. Marković, A., Mišić, T., Janjić, B., et al.[2022]

In a study involving 2 mongrel dogs, all 32 implants with different surface properties successfully osseointegrated after being immediately loaded with bridges just 2 days post-implantation, indicating that immediate loading can be effectively applied across various implant systems.

The study found that while all implants achieved good stability, mandibular implants showed significantly higher resonance frequency values compared to maxillary implants, suggesting that implant location may influence stability outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Immediate implant loading with fixed dental restorations--an animal model study]. Gostović, AS., Todorović, A., Lazić, V., et al.[2019]

Immediate loading of two implants for overdentures in edentulous patients is as effective as traditional delayed loading, providing similar retention and functional benefits.

This new approach not only maintains treatment efficacy but also reduces costs, making it a viable option for improving the quality of life for patients with lower denture retention issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Prosthetic dilemmas. Immediate versus conventional loading of implants in the edentulous mandible]. Stoker, GT., Wismeijer, D.[2008]

In a study of 49 patients needing full-arch treatment in the upper jaw, immediate loading of implants (Columbus Bridge Protocol) showed similar survival rates to delayed loading (Branemark protocol) after 36 months, with 6.1% failure in the immediate group and 4.1% in the delayed group.

The immediate loading group experienced significantly less bone loss over 3 years, with average bone levels of 1.6 mm compared to 2.3 mm in the delayed loading group, indicating a potential advantage in preserving bone health with immediate implant loading.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate versus delayed loading of dental implants in edentulous maxillae: a 36-month prospective study. Tealdo, T., Bevilacqua, M., Menini, M., et al.[2022]

A systematic review of 7 studies involving 191 participants found that immediate loading (ILP) of unsplinted mandibular implant-retained overdentures resulted in marginal bone loss (MBL) comparable to delayed loading (DLP), indicating that ILP is a viable option for patients seeking immediate aesthetics and function.

The implant failure rate was higher in the immediate loading group (5.03%) compared to the delayed loading group (1.00%), suggesting that while ILP is effective, there may be a slightly increased risk of implant failure that should be considered.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of immediate and delayed loading protocols on marginal bone loss around implants in unsplinted mandibular implant-retained overdentures: a systematic review and meta-analysis. Liu, W., Cai, H., Zhang, J., et al.[2023]

In a study involving 41 patients treated with 343 dental implants, an impressive success rate of 99.42% was achieved for immediately loaded implants, demonstrating the efficacy of this approach for full-arch restorations.

The study monitored bone levels over time, showing minimal changes (average of 0.94 mm over 72 months), indicating good bone stability around the implants after immediate loading.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immediate occlusal loading of double acid-etched surface titanium implants in 41 consecutive full-arch cases in the mandible and maxilla: 6- to 74-month results. Ibañez, JC., Tahhan, MJ., Zamar, JA., et al.[2022]

In a study involving 20 completely edentulous patients, those with delayed loading of two implants for mandibular overdentures reported higher satisfaction in comfort, speech, function, pain, and chewing efficiency compared to those with immediate loading.

The findings suggest that delayed loading protocols may lead to better clinical outcomes and a higher success rate for implant-supported overdentures than immediate loading.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparative evaluation of immediate versus delayed loading of two implants with mandibular overdenture: An in vivo study. Singh, PD., Kumar, V., Arya, G.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8739250/

Patient-reported outcomes with immediate-loaded two- ... The purpose of the study was to evaluate patient-reported outcomes of immediately loaded two-implant-supported overdentures retained by ball attachments over a ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S277255962200013X

Revisiting maxillary implant overdentures in 2022: A topic ... One-stage surgery and early loading of three implants for maxillary overdentures: A 1-year report. Clin Implant Dent Relat Res, 6 (2004), pp. 61-74. Crossref ...

3. thejcdp.com thejcdp.com/doi/10.5005/jp-journals-10024-1621

Early and Immediate Loading Protocols for Overdentures in ... Short term reports demonstrate that immediate/early loading of dental implants with a maxillary overdenture is a predictable treatment approach and results.

4. medicaljournalssweden.se medicaljournalssweden.se/actaodontologica/article/download/42027/47932?inline=1

Efficacy of immediate loading compared to conventional ... Conclusion: Lower implant survival rates and a decrease in marginal bone level was observed compared to immediate loading with conventional loading. KEYWORDS: ...

5. withpower.com withpower.com/trial/phase-implant-complication-1-2023-9772a

Immediate vs Delayed Loading of Dental Implants for ... The purpose of the study is to evaluate the radiographic, clinical and patient-centered outcomes of implant-retained immediately-loaded ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9648956/

Impact of immediately loaded implant-supported maxillary full ... The immediate loading of implant-assisted fixed prostheses in edentulous maxillae may achieve favorable success rates with reduced treatment time.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11129804/

Risk factors for implant-supported overdenture failures The current study defines implant failure as any: Osseointegration defect (immediate or early loading by provisional prosthesis of a nonembedded implant) ...

8. speareducation.com speareducation.com/2021/10/loading-protocols-implant-overdentures

Loading Protocols for Implant Overdentures The original Branemark loading concepts suggested leaving dental implants submerged for between three and six months before uncovering the fixtures and ...