Dental ImplantsNCT06948734
Longitudinal Assessment of Adjacent Tooth Health Following Implant Placement
An observational study of Dental Implants and Postoperative Period, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Postoperative Period, Endodontics
- What is being tested?
- Clinical and radiographic examination
- How many people
- 31 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jul 2023to 10 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cukurova University Faculty of Dentistry Department of Endodontics
Adana, Sarıcam, 01250
About this study
Official title: Longitudinal Monitoring of Pulpal and Periapical Health of Adjacent Natural Teeth Before and After 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.
Read the 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.
- Conditions
- Dental Implants, Postoperative Period, Endodontics, Health
- Being tested
- Clinical and radiographic examination
- Keywords
- Dental implants, Postoperative monitoring, Adjacent teeth, Pulpal health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and radiographic examinationDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Clinical and radiographic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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'.
Measured: At the preoperative stage and during postoperative follow-up at 3 months the tests were performed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start5 Jul 2023
- Primary completion10 Oct 2024
- Study completion10 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helin Kussever, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06948734
- Sponsor's protocol ID
- 2023/134/53
- Status last verified
- Nov 2024
- First submitted
- 18 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kussever H, Yilmaz S, Topcu BE, Kuden C. Longitudinal monitoring of pulpal and periapical health of adjacent natural teeth during the implant healing period: a prospective cohort study. BMC Oral Health. 2026 Jul 14. doi: 10.1186/s12903-026-09211-8. Online ahead of print.
PubMed 42443876
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Monitoring of Pulpal and Periapical Health of Adjacent Natural Teeth Before and After Implant Placement
- ClinicalTrials.gov ID
- NCT06948734
- Acronym / sponsor ID
- 2023/134/53
- Conditions
- Dental Implants, Postoperative Period, Endodontics, Health
- Keywords
- Dental implants, Postoperative monitoring, Adjacent teeth, Pulpal health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 5 Jul 2023 (actual)
- Primary completion
- 10 Oct 2024 (actual)
- Study completion
- 10 Oct 2024 (actual)
- First posted
- 29 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for implant placement in edentulous sites adjacent to natural teeth | – | Diagnostic Test: Clinical and radiographic examinationPatients scheduled to receive multiple implants at different time points, in edentulous sites adjacent to natural teeth, based on individualized surgical planning. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and radiographic examinationIn 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. | Diagnostic test | Patients scheduled for implant placement in edentulous sites adjacent to natural teeth |
Primary outcome
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.
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.
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.
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'.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2025.
- Derived from this study: PubMed 42443876Kussever H, Yilmaz S, Topcu BE, Kuden C. Longitudinal monitoring of pulpal and periapical health of adjacent natural teeth during the implant healing period: a prospective cohort study. BMC Oral Health. 2026 Jul 14. doi: 10.1186/s12903-026-09211-8. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dental Implants and Postoperative Period, run by Cukurova University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06948734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2025.