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

Trial Summary

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.

What data supports the effectiveness of the treatment for immediate vs delayed loading of dental implants?

Research shows that immediate loading of dental implants can be as successful as delayed loading, with similar implant stability and improved patient satisfaction and quality of life, especially in terms of reduced pain and better aesthetics. ^{1 2 3 4 5}

Is immediate or delayed loading of dental implants safe for humans?

Research shows that both immediate and delayed loading of dental implants are generally safe, with no significant differences in implant stability after 6 weeks. Immediate loading may improve patient satisfaction and quality of life, especially in terms of reduced pain and better aesthetics. ^{1 2 6 7 8}

How does the treatment of immediate vs delayed loading of maxillary implant overdentures differ from other treatments for dental implant complications?

This treatment is unique because it compares two approaches: immediate loading, where the dental implants are used right away, and delayed loading, where there is a waiting period before use. Immediate loading can offer quicker aesthetic and functional results, while delayed loading follows a more traditional approach, allowing more time for healing before the implants are used. ^{1 3 6 8 9}

What is the purpose of this trial?

The purpose of the study is to evaluate the radiographic, clinical and patient-centered outcomes of implant-retained immediately-loaded maxillary complete dentures in comparison to delayed loading approach by primarily evaluating radiographic bone loss of dental implants placed in the maxilla over 36 months

Research Team

Gian P Schincaglia, DDS, PhD

Principal Investigator

Case Western Reserve University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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]

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]

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]

References

1. England 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. [2023]

2. United States 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. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

[Prosthetic dilemmas. Immediate versus conventional loading of implants in the edentulous mandible]. [2008]

4. United States pubmed.ncbi.nlm.nih.gov

Immediate versus delayed loading of dental implants in edentulous maxillae: a 36-month prospective study. [2022]

5. India pubmed.ncbi.nlm.nih.gov

A comparative evaluation of immediate versus delayed loading of two implants with mandibular overdenture: An in vivo study. [2022]

6. United States 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. [2023]

7. Serbia pubmed.ncbi.nlm.nih.gov

[Immediate implant loading with fixed dental restorations--an animal model study]. [2019]

8. United States 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. [2022]

9. United States 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. [2022]