Clinical trial NCT06948734: Longitudinal Assessment of Adjacent Tooth Health Following Implant Placement
Official title: Longitudinal Monitoring of Pulpal and Periapical Health of Adjacent Natural Teeth Before and After Implant Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dental Implants
Postoperative Period
Endodontics
Health
Keywords: Dental implants
Postoperative monitoring
Adjacent teeth
Pulpal health
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2025-04-29
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percussion and Pulpal Diagnostic Test Outcomes
timeFrame: At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
measure: Palpation Test Outcomes
timeFrame: At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
measure: Measurement of pain scores using the Numeric Pain Rating Scale (NPRS)
timeFrame: At the preoperative stage and during postoperative follow-ups at 1 week, 1 month, and 3 months the tests were performed.
measure: Assessment of Radiological Outcomes
timeFrame: At the preoperative stage and during postoperative follow-up at 3 months the tests were performed.
Secondary outcomes:
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Dentistry Department of Endodontics
state: Sarıcam
Study officials:
References: