Comparison of Replantation and Splinting Alone in Lower Anterior Teeth

NCT07141680 | Recruiting DMC

• 1 other identifier: 24-7
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Periodontitis

Keywords

intentional replantation; periodontal splint; tooth mobility; tooth reimplantation; tooth replantation

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline and 6th monts

Secondary Outcomes (6)

• Probing pocket depth (PPD)

  Baseline, 3rd and 6th months

• Bleeding on probing (BOP)

  Baseline, 3rd and 6th months

• Mobility

  Baseline, 3rd and 6th months

• Gingival index (GI)

  Baseline, 3rd and 6th months

• Plaque index (PI)

  Baseline, 3rd and 6th months

Study Arms (2)

Replantation

ACTIVE COMPARATOR

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

Procedure: Replantation

Splint

PLACEBO COMPARATOR

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

Procedure: Splint

Interventions

Replantation PROCEDURE

Root canal treatment Tooth extraction and replacement Splinting

Replantation

Splint PROCEDURE

Root canal treatment Splinting

Splint

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Systemic Comorbidity
• Smoking
• Root Resorption
• Root Fracture or Crack
• Ankylosis of the Tooth

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

University of Health Sciences, Hamidiye Faculty of Dentistry.

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Periodontitis; Tooth Mobility

Interventions

Replantation; Splints

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative; External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Central Study Contacts

Tuğçe PAKSOY associate professor

CONTACT

+90 553 449 04 52; tugce.paksoy@sbu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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.

Study Record Dates

• First Submitted: August 18, 2025
• First Posted: August 26, 2025
• Study Start: May 24, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)