Effect of Placing the Implant Crown on the Implant on the Same Day as the Implant vs. 4 Weeks Later.

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorUniversity of Bern

About this trial

In this study, participants with one lower first molar that require removal and replacement using dental implants will be enrolled. The implant will be inserted 12-16 weeks after tooth extraction and restored either immediately with an artificial tooth (fixed implant crown) in 50% of the cases or 4 weeks later in the remainder 50%. Immediate and early loading will be compared and the investigators expect no difference in terms of implant success and health of the tissue around the implant.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 20 years

Willingness to sign informed consent and to participate in the study

Plaque index according to Silness and Loe of < 35% [26]

Presence of a mandibular first molar that has to be extracted

Disqualifiers

Any physical or mental disorder that would interfere with the ability to perform adequate oral hygiene or the capability of providing written informed consent and compliance to the protocol

Any disorder that would interfere with wound healing or represent a contraindication for implant surgery such as, but not limited to, uncontrolled diabetes or conditions resulting in or requiring immunosuppression, radiation, chemotherapy, frequent use of antibiotics or antiresorptive medication such as bisphosphonates

Pregnancy or lactation

Intention to become pregnant between inclusion and implant loading

Trial design

Design model

Parallel

Treatments tested in this trial

  • Immediate Loading

    Procedure/Surgery

    The implant receives an artificial tooth the same day as it is placed.

  • Early Loading

    Procedure/Surgery

    The implant receives an artificial tooth 4 weeks after placement.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Immediate LoadingActive comparator 1 intervention
Group B: Early LoadingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Implant Survival

Number of implants from both groups (i.e. immediate loading vs. early loading) fulfilling the criteria of survival and success after 12 months. The criteria are: * Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (e. g. painful sensation) * Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if observed at two or more follow-up visits after the treatment with systemic antibiotics) * Absence of implant mobility on manual palpation * Absence of any continuous peri-implant radiolucency

Time frame
12 months

Secondary outcomes

1

Prosthetic Success

Esthetics and correct function of the implant prosthetic will be analyzed by means of palpation, inspection and probing. Any prosthetic complication, e.g. chipping, screw loosening will be recorded.

Time frame
10 years
2

Patient's satisfaction

Patient's satisfaction with the treatment result will be analyzed by means of questions (both oral and written, using validated questionnaires)

Time frame
10 years
3

Clinical peri-implant soft tissue dimensions

Probing depth of the soft tissue surrounding the implant will be assessed using palpation, inspection and a periodontal probe.

Time frame
10 years
4

Crestal bone level

Crestal bone-level changes will be assessed in the follow-up radiographs that are taken routinely after any implant treatment, using a dedicated imaging software.

Time frame
10 years

Other outcomes

Sponsors and contacts

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