- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06948734
Longitudinal Assessment of Adjacent Tooth Health Following Implant Placement
Longitudinal Monitoring of Pulpal and Periapical Health of Adjacent Natural Teeth Before and After Implant Placement
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Sarıcam
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Adana, Sarıcam, Turkey, 01250
- Cukurova University Faculty of Dentistry Department of Endodontics
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Age between 18 and 65 years ASA I or II classification At least one vital adjacent tooth at implant site Adjacent tooth free of pulpal/periapical pathology Not prosthetically restored; unrestored or restored with composite material Sites allowing a tooth-implant distance of ≥1.5 mm Patients scheduled to receive multiple implants at different time points based on surgical planning
Exclusion Criteria:
Age <18 or >65 ASA physical status classification ≥ III Absence of adjacent teeth at implant site Undergoing or planned advanced implant procedures (e.g., bone grafting, sinus lifting, nerve lateralization/transposition) Adjacent teeth devital, with periapical pathology, root canal treated, or prosthetically rehabilitated
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients scheduled for implant placement in edentulous sites adjacent to natural teeth
Patients scheduled to receive multiple implants at different time points, in edentulous sites adjacent to natural teeth, based on individualized surgical planning.
|
In order to evaluate the pulpal and periapical health of natural teeth adjacent to dental implants at specific time intervals, percussion, palpation, and pulpal diagnostic tests were performed, and the presence of any pathological changes was monitored using radiographic examinations.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percussion and Pulpal Diagnostic Test Outcomes
Time Frame: At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
|
At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months, vertical percussion was performed on the natural teeth adjacent to the dental implant by gently placing a dental probe under its own weight.
The response was recorded as either positive or negative.
Electric pulp test and cold test (pulpal diagnostic tests) were also performed on the adjacent teeth at the same time intervals.
Numerical responses were recorded for the electric pulp test, while responses to the cold test were documented as either positive or negative.
|
At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
|
|
Palpation Test Outcomes
Time Frame: At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
|
To assess the presence or absence of tenderness upon palpation, a bidigital palpation test was performed during the preoperative phase and at postoperative follow-up visits at 1 week, 1 month, and 3 months.
The response was recorded as either positive or negative.
|
At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
|
|
Measurement of pain scores using the Numeric Pain Rating Scale (NPRS)
Time Frame: At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
|
At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months, patients were asked to indicate the number corresponding to the intensity of pain they experienced on a 0-10 Numerical Rating Scale (NRS), and the selected values were recorded.
|
At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
|
|
Assessment of Radiological Outcomes
Time Frame: At the preoperative stage and during postoperative follow-up at 3 months the tests were performed.
|
Periapical status of the natural teeth adjacent to the dental implants was assessed radiographically at baseline and at the 3-month postoperative follow-up.
Radiographs were evaluated for the presence of any periapical pathology, and outcomes were documented as either 'radiolucent area present' or 'radiolucent area absent'.
|
At the preoperative stage and during postoperative follow-up at 3 months the tests were performed.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023/134/53
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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