PeriodontitisNCT07141680
Comparison of Replantation and Splinting Alone in Lower Anterior Teeth
A study testing Replantation and Splint in people with Periodontitis, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Replantation is defined as the intentional extraction and repositioning of teeth that have lost their periodontal support. The aim of this study is to evaluate the clinical and radiographic follow-up results of planned replantation treatment in cases with advanced periodontal destruction and to compare it with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Periodontitis
- What is being tested?
- Replantation and Splint
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 May 2025to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients are systemically healthy or have their systemic conditions under control.
- Lower anterior incisors (42, 41, 31, 32) will be included.
- Mobility classification will be Miller 3.
- Radiograph showing 50% or more bone loss at the root.
- Probing depth of 5 mm or more.
- Bone level of adjacent teeth at ⅔ or better than the root.
- Mobility of adjacent teeth will be Miller 0 or Miller 1.
- The patient prefers to keep the tooth in the mouth rather than having it extracted.
Who cannot join
- Systemic Comorbidity
- Smoking
- Root Resorption
- Root Fracture or Crack
- Ankylosis of the Tooth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Hamidiye Faculty of Dentistry.
Istanbul
About this study
Official title: Clinical and Radiographic Evaluation of Intentional Replantation Treatment in Periodontally Hopeless Teeth, Randomized Controlled Clinical Study
Replantation is defined as the intentional extraction and repositioning of teeth that have lost their periodontal support. The aim of this study is to evaluate the clinical and radiographic follow-up results of planned replantation treatment in cases with advanced periodontal destruction and to compare it with splinting alone.
Twenty-five patients with periodontal damage in the control group and 25 patients in the experimental group will be included in the study. The clinical parameters of both groups will be evaluated at baseline, 1, 3, and 6 months using periodontal indices and the Visual Analog Scale (VAS).
Read the detailed description
Fifty individuals aged 18-65 with severe clinical attachment loss (>3 mm) and alveolar bone loss (⅔ or more of the root) in their lower anterior incisors will participate in the study, taking into account the inclusion and exclusion criteria. All patients will undergo non-surgical periodontal treatment before being divided into groups. Patients who meet the inclusion criteria will be randomly selected for the experimental and control groups:
Control group (n=25): The group that will undergo conventional root canal treatment and be followed up with a splint Experimental group (n=25): The group that will undergo conventional root canal treatment followed by planned replantation treatment and splinting.
Infiltrative anesthesia is applied to the tooth planned for replantation. The tooth is extracted with care not to cause trauma to the surrounding tissues. Care is taken not to touch the root surface of the extracted tooth, especially in areas where it comes into contact with the bone apically, in order not to damage the cells that promote healing. If there are attachments on the root surface, they are removed with ultrasound. The tooth is placed in the prepared tetracycline solution and left for 5 minutes. During this time, the extraction socket is gently checked to ensure it is clean. Any granulation tissue that would prevent the tooth root from settling into the bone and making contact is removed. The tooth is removed from the tetracycline solution and placed in the socket. The tooth is stabilized and a temporary splint is applied. Contacts are removed during closure and intrusive movements. The patient is informed that they should not bite or tear with their front teeth and that they should protect the tooth. After 2 weeks, a permanent periodontal splint will be applied.
The clinical parameters of the patients participating in the study will be monitored for 6 months, and the success of the planned replantation treatment will be evaluated by comparing the data from the control group and the test group. It will be investigated whether there is a significant difference between the treatments applied to the control and test groups in terms of clinical and radiographic findings and patient satisfaction.
- Conditions
- Periodontitis
- Being tested
- Replantation, Splint
- Keywords
- intentional replantation, periodontal splint, tooth mobility, tooth reimplantation, tooth replantation
- Medical subject headings
- Periodontitis, Tooth Mobility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReplantationProcedure or surgery
Root canal treatment Tooth extraction and replacement Splinting
SplintProcedure or surgery
Root canal treatment Splinting
| Study group | Role | What they receive |
|---|---|---|
| Replantation | Active comparator | Replantation group (n=25): Group that underwent conventional canal treatment followed by planned replantation treatment and splinting. Receives: Procedure: Replantation |
| Splint | Placebo comparator | Splint group (n=25): The group that will undergo conventional canal treatment and splinting. Receives: Procedure: Splint |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical attachment loss (CAL)
CAL is measured as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus (the most coronal attachment) using a Williams periodontal probe. The changes in clinical attachment loss was measured for determining the severity of disease.
Measured: Baseline, 3rd and 6th months
Bone Loss,(BL)
The pre- and post-treatment tooth length/bone ratio around the tooth root will be determined using CBCT and periapical radiographs. The amount of bone loss (% bone loss, BL) will be determined using a millimeter scale from both the mesial and distal regions of the teeth, according to the method described by Schulte and colleagues (10) using periapical radiographs. To determine individual bone loss, intra-alveolar root length (hi) and total root length (hg) are measured. Hg, the total root length, is defined as the distance from the apex to the proximal enamel-cementum junction, parallel to the long axis of the teeth. Since the distance between the alveolar bone crest and the enamel-cementum junction varies between 0.75 and 1.49 mm, 1.5 mm is subtracted from the total root length during calculation. The intra-alveolar root length is defined as the distance from the apex to the highest point on the alveolar margin. The change in bone loss at baseline and at 6 months will be examined.
Measured: Baseline and 6th monts
Secondary outcomes (6)
Probing pocket depth (PPD)
Probing pocket depth (PPD) measured as the change in distance from the gingival margin to the bottom of the gingival sulcus using a Williams periodontal probe.
Measured: Baseline, 3rd and 6th months
Bleeding on probing (BOP)
All six sites of all teeth were probed to assess whether this elicited bleeding (+) or not (-). The severity of gingival inflammation was expressed as a percentage (BOP=number of bleeding sites×100/number of sites evaluated).
Measured: Baseline, 3rd and 6th months
Mobility
Tooth mobility will be assessed using a 5N (500g) manual measurement. Changes in mobility will be examined with treatment.
0th degree: no mobility
- st degree: slight movement
- nd degree: up to 1 mm
- rd degree: more than 1 mm and movement in all directions vertical mobility
Measured: Baseline, 3rd and 6th months
Gingival index (GI)
To determine the gingival index (Löe \& Silness), gingival bleeding caused by running a Williams periodontal probe inside the pocket on the mesial, distal, buccal, and palatal surfaces of all teeth was evaluated. The gingival index of an individual was obtained by summing the values determined for each tooth and calculating the averages. Scoring was as follows:
0: Healthy gums.
- Mild discolouration and oedematous gingiva. No bleeding on probing.
- Red, oedematous and shiny gingiva. There is bleeding on probing.
- Red, oedematous and ulcerated gingiva. There is spontaneous bleeding. Gingival index was recorded for classifying and evaluating sulcular gingival inflammation.
Measured: Baseline, 3rd and 6th months
Plaque index (PI)
Patients' plaque indices will be recorded according to the Silness and Löe plaque index. After the teeth are dried with air, the amount of plaque near the gingival margin of each tooth is examined with an inspection and examination probe. Index values between 0 and 3 are given according to the amount of plaque on the tooth surface.
According to this index:
0: No plaque.
- A thin layer of plaque is observed along the gingival margin. This thin layer can be detected with an examination probe.
- A moderate layer of plaque is observed along the gingival margin. The plaque in question can be detected with the naked eye.
- A significant amount of plaque is observed along the gingival margin, and the interdental spaces are filled with plaque.
Measured: Baseline, 3rd and 6th months
VAS measurement values
VAS is the most commonly used scale for measuring pain intensity and tracking the degree of pain relief. VAS is a 10 cm line with the extremes of "no pain" and "worst possible pain," and the measurement is determined by the patient marking the line that best describes their pain intensity. The average of the values obtained for patients is calculated.
Measured: Baseline, 3rd and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start24 May 2025
- Primary completionOct 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Fifty individuals aged 18-65 with severe clinical periodontal attachment loss (\>3 mm) and alveolar bone loss (⅔ or more of the root) in the anterior incisors will participate in the study, taking into account the inclusion and exclusion criteria. All patients will undergo non-surgical periodontal treatment before being divided into groups. Patients who meet the inclusion criteria for the study will be randomly selected into the experimental and control groups: 1. Control group (n=25): The group that will undergo conventional root canal treatment and be followed up with a splint. 2. Experimental group (n=25): The group that will undergo conventional root canal treatment followed by planned replantation treatment and be followed up with a splint.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğçe Paksoy, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07141680
- Sponsor's protocol ID
- 24-7
- Status last verified
- Sep 2026
- First submitted
- 18 Aug 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no need for such a sharing
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Evaluation of Intentional Replantation Treatment in Periodontally Hopeless Teeth, Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07141680
- Acronym / sponsor ID
- 24-7
- Conditions
- Periodontitis
- Keywords
- intentional replantation, periodontal splint, tooth mobility, tooth reimplantation, tooth replantation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 24 May 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Aug 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.
Replantation is defined as the intentional extraction and repositioning of teeth that have lost their periodontal support. The aim of this study is to evaluate the clinical and radiographic follow-up results of planned replantation treatment in cases with advanced periodontal destruction and to compare it with splinting alone.
Twenty-five patients with periodontal damage in the control group and 25 patients in the experimental group will be included in the study. The clinical parameters of both groups will be evaluated at baseline, 1, 3, and 6 months using periodontal indices and the Visual Analog Scale (VAS).
Detailed description
Fifty individuals aged 18-65 with severe clinical attachment loss (>3 mm) and alveolar bone loss (⅔ or more of the root) in their lower anterior incisors will participate in the study, taking into account the inclusion and exclusion criteria. All patients will undergo non-surgical periodontal treatment before being divided into groups. Patients who meet the inclusion criteria will be randomly selected for the experimental and control groups:
Control group (n=25): The group that will undergo conventional root canal treatment and be followed up with a splint Experimental group (n=25): The group that will undergo conventional root canal treatment followed by planned replantation treatment and splinting.
Infiltrative anesthesia is applied to the tooth planned for replantation. The tooth is extracted with care not to cause trauma to the surrounding tissues. Care is taken not to touch the root surface of the extracted tooth, especially in areas where it comes into contact with the bone apically, in order not to damage the cells that promote healing. If there are attachments on the root surface, they are removed with ultrasound. The tooth is placed in the prepared tetracycline solution and left for 5 minutes. During this time, the extraction socket is gently checked to ensure it is clean. Any granulation tissue that would prevent the tooth root from settling into the bone and making contact is removed. The tooth is removed from the tetracycline solution and placed in the socket. The tooth is stabilized and a temporary splint is applied. Contacts are removed during closure and intrusive movements. The patient is informed that they should not bite or tear with their front teeth and that they should protect the tooth. After 2 weeks, a permanent periodontal splint will be applied.
The clinical parameters of the patients participating in the study will be monitored for 6 months, and the success of the planned replantation treatment will be evaluated by comparing the data from the control group and the test group. It will be investigated whether there is a significant difference between the treatments applied to the control and test groups in terms of clinical and radiographic findings and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Fifty individuals aged 18-65 with severe clinical periodontal attachment loss (>3 mm) and alveolar bone loss (⅔ or more of the root) in the anterior incisors will participate in the study, taking into account the inclusion and exclusion criteria. All patients will undergo non-surgical periodontal treatment before being divided into groups. Patients who meet the inclusion criteria for the study will be randomly selected into the experimental and control groups: 1. Control group (n=25): The group that will undergo conventional root canal treatment and be followed up with a splint. 2. Experimental group (n=25): The group that will undergo conventional root canal treatment followed by planned replantation treatment and be followed up with a splint.
| Arm | Type | Receives |
|---|---|---|
| Replantation | Active comparator | Procedure: ReplantationReplantation group (n=25): Group that underwent conventional canal treatment followed by planned replantation treatment and splinting. |
| Splint | Placebo comparator | Procedure: SplintSplint group (n=25): The group that will undergo conventional canal treatment and splinting. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- All patients are systemically healthy or have their systemic conditions under control.
- Lower anterior incisors (42, 41, 31, 32) will be included.
- Mobility classification will be Miller 3.
- Radiograph showing 50% or more bone loss at the root.
- Probing depth of 5 mm or more.
Key exclusion criteria (5 listed)
- Systemic Comorbidity
- Smoking
- Root Resorption
- Root Fracture or Crack
- Ankylosis of the Tooth
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 |
|---|---|---|
| ReplantationRoot canal treatment Tooth extraction and replacement Splinting | Procedure or surgery | Replantation |
| SplintRoot canal treatment Splinting | Procedure or surgery | Splint |
Primary outcome
Clinical attachment loss (CAL)
Time frame: Baseline, 3rd and 6th months
CAL is measured as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus (the most coronal attachment) using a Williams periodontal probe. The changes in clinical attachment loss was measured for determining the severity of disease.
Bone Loss,(BL)
Time frame: Baseline and 6th monts
The pre- and post-treatment tooth length/bone ratio around the tooth root will be determined using CBCT and periapical radiographs. The amount of bone loss (% bone loss, BL) will be determined using a millimeter scale from both the mesial and distal regions of the teeth, according to the method described by Schulte and colleagues (10) using periapical radiographs. To determine individual bone loss, intra-alveolar root length (hi) and total root length (hg) are measured. Hg, the total root length, is defined as the distance from the apex to the proximal enamel-cementum junction, parallel to the long axis of the teeth. Since the distance between the alveolar bone crest and the enamel-cementum junction varies between 0.75 and 1.49 mm, 1.5 mm is subtracted from the total root length during calculation. The intra-alveolar root length is defined as the distance from the apex to the highest point on the alveolar margin. The change in bone loss at baseline and at 6 months will be examined.
6 secondary outcomes
Probing pocket depth (PPD)
Time frame: Baseline, 3rd and 6th months
Bleeding on probing (BOP)
Time frame: Baseline, 3rd and 6th months
Mobility
Time frame: Baseline, 3rd and 6th months
Gingival index (GI)
Time frame: Baseline, 3rd and 6th months
Plaque index (PI)
Time frame: Baseline, 3rd and 6th months
VAS measurement values
Time frame: Baseline, 3rd and 6th months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No. There is no need for such a sharing
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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?
A study testing Replantation and Splint in people with Periodontitis, run by Saglik Bilimleri Universitesi 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 8 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical attachment loss (CAL) (time frame: Baseline, 3rd and 6th months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.