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Enrolling by invitation NCT07732647

Immediate Implant Provisionalization

No phase Interventional Gum Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dental implant placement.
Who it may be relevant to
Registry conditions: Gum Disease. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Soft Tissue Stability of Immediate Implant Placement With and Without Immediate Provisionalization: A Randomized Controlled Clinical Trial

Overview

This research is studying gum tissue stability of dental implants placed at same appointment as the tooth extraction, with or without a provisional (temporary) crown.

Detailed description

This study aims to find out whether a new type of hybrid dental implant-which has a smooth surface near the gums to make cleaning easier and potentially lower the risk of infection-can help improve gum health and reduce implant complications. It also compares two common treatment approaches after tooth removal: placing a temporary provisional crown immediately versus using a standard healing cap. By studying these options, we hope to learn which method provides better healing, protects the gums more effectively, and leads to fewer problems around the implant.

Interventions

  • Device Dental implant placement
    A dental implant will be placed after tooth extraction.

Primary outcome measures

  • Linear changes of gum tissue architecture [Time frame: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery]
  • Volumetric changes of gum tissue architecture [Time frame: 1 month and 4 months after baseline surgery, 6 months and 12 months after crown delivery]
Secondary outcome measures (3)
  • Changes in marginal bone [Time frame: 5 months after baseline surgery, 6 months and 12 months after crown delivery]
  • Patient-reported satisfaction [Time frame: 14 days after baseline surgery]
  • Microbial profile [Time frame: Baseline, 4 months after baseline surgery, 6 months and 12 months after crown delivery]

Eligibility criteria

Inclusion criteria

  • Age ≥ 18 years
  • Physical status according to the American Society of Anesthesiology (ASA) I or II, which include patients who are systematically healthy or may suffer from mild to moderate, however well-controlled systemic diseases.
  • Periodontally healthy or with treated periodontitis with good oral hygiene ((FMPS) and (FMBS) ≤15%, measured at four sites per tooth).
  • Presence of one non-restorable maxillary anterior tooth (from #5 to #12 sites)
  • More than 20 occluding teeth with stable occlusion.
  • Nonsmokers or smokers < 10 cig/day (self-reported).

Exclusion criteria

  • Presence of uncontrolled or untreated periodontal disease.
  • Presence of active periapical infection.
  • Subjects taking medications known to modify bone metabolism or those that can interfere with the normal wound healing (such as bisphosphonates, corticosteroids, hormone replacement therapy, parathyroid hormone, denosumab, strontium ranelate, etc.), or those with uncontrolled systemic diseases or conditions that may similarly affect the patient's healing (osteoporosis, osteopenia, hyperparathyroidism, Paget's disease, uncontrolled diabetes (HBA1c > 8)).
  • Pregnant subjects or individuals attempting to get pregnant (self-reported)
  • Subjects smoking 10 or more cigarettes a day, or those with a history of drug or alcohol abuse (self-reported)
  • Subjects unable to maintain adequate oral hygiene
  • Insufficient restorative space or bite collapse.
  • Lack of primary implant stability assessed intrasurgically.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of Michigan School of Dentistry — Ann Arbor

Identifiers

NCT: NCT07732647 · HUM00275903

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗