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Completed

NCT Number: NCT06948734

Longitudinal Assessment of Adjacent Tooth Health Following Implant Placement

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.

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Key information

Conditions

Dental Implants Endodontics Health Postoperative Period

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cukurova University Faculty of Dentistry Department of Endodontics

Adana, Sarıcam, 01250, Turkey (Türkiye)

About this study

Modern implantology began in 1965 with the placement of four intraosseous titanium implants in a patient with a mandibular defect, marking the introduction of the concept of osseointegration. Since then, dental implants have emerged as a reliable and effective treatment modality for the rehabilitation of edentulous spaces. This longitudinal cohort study aims to evaluate whether dental implants placed in edentulous sites adjacent to natural teeth lead to alterations in the endodontic condition of these neighboring teeth. Specifically, the study investigates the nature and extent of any pulpal or periapical changes in adjacent teeth following implant placement. It is hypothesized that any damage to the adjacent teeth may be attributed to intraoperative complications, iatrogenic factors, or physiological consequences associated with the healing of hard and soft tissues post-surgery. The short-term observation intervals (1 week, 1 month, and 3 months postoperatively) are expected to offer insights into the potential causes of endodontic symptoms that may arise in neighboring teeth. Through this design, the study seeks to better understand the etiological relationship between implant placement and the pulpal/periapical health of adjacent teeth.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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'.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

Longitudinal Monitoring of Pulpal and Periapical Health of Adjacent Natural Teeth Before and After Implant Placement

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 29, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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