Longitudinal Assessment of Adjacent Tooth Health Following Implant Placement

NCT06948734 | Completed DMC

• 1 other identifier: 2023/134/53
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a cohort investigation involving patients scheduled to receive dental implants in edentulous sites adjacent to natural teeth. Individuals aged between 18 and 65 years, without any systemic diseases and possessing natural teeth adjacent to the planned implant sites, were included. Clinical and radiographic evaluations were conducted preoperatively, and at 1 week, 1 month, and 3 months following implant placement. The null hypotheses (H0) of this study are as follows: First, there is no significant difference in the clinical parameters of adjacent teeth before and after implant surgery. Second, there is no significant change in the radiological parameters in adjacent teeth between the preoperative and postoperative periods.

Conditions

Dental Implants; Postoperative Period; Endodontics; Health

Keywords

Dental implants; Postoperative monitoring; Adjacent teeth; Pulpal health

Outcome Measures

Primary Outcomes (4)

• Percussion and Pulpal Diagnostic Test Outcomes

  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

  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)

  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

  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.

Study Arms (1)

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.

Diagnostic Test: Clinical and radiographic examination

Interventions

Clinical and radiographic examination DIAGNOSTIC_TEST

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.

Patients scheduled for implant placement in edentulous sites adjacent to natural teeth

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 18 and 65 years, without any systemic diseases, who were scheduled to receive multiple dental implants at different time points in edentulous sites adjacent to natural teeth, based on individualized surgical planning

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cukurova University: lead

Study Sites (1)

Cukurova University Faculty of Dentistry Department of Endodontics

Adana, Sarıcam, 01250, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Diagnostic Imaging

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: April 29, 2025
• Study Start: July 5, 2023
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: April 29, 2025

Record last verified: 2024-11

Locations

TU (1)