Comparison of Replantation and Splinting Alone in Lower Anterior Teeth

NCT ID: NCT07141680

Last Updated: 2025-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-24

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Replantation

Replantation group (n=25): Group that underwent conventional canal treatment followed by planned replantation treatment and splinting.

Group Type ACTIVE_COMPARATOR

Replantation

Intervention Type PROCEDURE

Root canal treatment Tooth extraction and replacement Splinting

Splint

Splint group (n=25): The group that will undergo conventional canal treatment and splinting.

Group Type PLACEBO_COMPARATOR

Splint

Intervention Type PROCEDURE

Root canal treatment Splinting

Interventions

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Replantation

Root canal treatment Tooth extraction and replacement Splinting

Intervention Type PROCEDURE

Splint

Root canal treatment Splinting

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Systemic Comorbidity
* Smoking
* Root Resorption
* Root Fracture or Crack
* Ankylosis of the Tooth
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saglik Bilimleri Universitesi

OTHER

Sponsor Role lead

Responsible Party

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Tuğçe Paksoy

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Health Sciences, Hamidiye Faculty of Dentistry.

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Tuğçe PAKSOY associate professor

Role: CONTACT

+90 553 449 04 52

Facility Contacts

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Tuğçe PAKSOY Assassociate professor

Role: primary

+90 553 449 04 52

Other Identifiers

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24-7

Identifier Type: -

Identifier Source: org_study_id

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