Study on Treatment Results and Bone Changes After Replanting Severely Affected Teeth - A Before-and-After Study.

November 20, 2025 updated by: University of Fujairah

Assessment of Treatment Outcomes and Alveolar Bone Changes Following Intentional Replantation of Hopeless Periodontally Involved Single-Rooted Teeth - A Pre-test, Post-test Interventional Study

This research aims to evaluate the effectiveness of intentional replantation (IR) as a treatment for single-rooted teeth diagnosed as hopeless due to true periodontic lesions. The study will assess changes in alveolar bone and periodontal tissues, symptom resolution, and patient-reported outcomes (satisfaction and quality of life) following the procedure. Cone beam computed tomography (CBCT) imaging will be used to track radiographic changes at baseline and 9 months, while clinical examinations will monitor symptom resolution, including pain, swelling, and tooth mobility.

The study is a single-arm pre-test, post-test interventional design conducted at the College of Dentistry, University of Science and Technology Fujairah (new name: University of Fujairah). Participants will include adults aged 18-70 with single-rooted teeth deemed hopeless due to periodontic lesions. Participants will undergo intentional replantation, and data will be collected through clinical examinations, radiographic images, and patient questionnaires at baseline and 9 months.

Statistical analysis will compare pre- and post-treatment outcomes using paired-samples t-tests or Wilcoxon signed-rank tests, depending on data normality. The study aims to provide a comprehensive evaluation of intentional replantation, contributing valuable insights into its clinical effectiveness for managing complex dental conditions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The intervention in this study is intentional replantation (IR) of periodontally compromised single-rooted teeth deemed hopeless. Patients are chosen according to specific criteria, ensuring that the teeth are amenable to restoration and devoid of vertical root fractures. Preoperative preparation entails radiographic evaluation via periapical or cone-beam computed tomography (CBCT), scaling and root planing, and antibiotic prophylaxis when warranted. The process commences with a non-traumatic extraction utilising periotome to maintain the integrity of the periodontal ligament (PDL). After extraction, the tooth is handled extraorally within 15 minutes to preserve periodontal ligament viability. It is preserved in a sterile medium, such as saline or blood, and granulation tissue is meticulously excised. Optional root modifications, such as apical resection, retrograde filling with mineral trioxide aggregate or biodentine, or surface treatment with tetracycline or enamel matrix derivatives like Emdogain, may be conducted if required. The tooth is subsequently replanted into its original socket and secured with a non-rigid splint (fiber-reinforced composite or orthodontic wire) for a duration of 2 to 4 weeks. Occlusal adjustment is conducted to reduce excessive functional forces. Postoperative care comprises analgesics, antibiotics as necessary, and a 0.12% chlorhexidine rinse administered bi-daily for a duration of two weeks. Patients are instructed to adhere to a soft diet for two weeks to avert trauma to the replanted tooth. Follow-up evaluations are planned at 1 week, 4 weeks, 9 months to evaluate healing, bone regeneration, periodontal reattachment, and overall tooth viability. The principal outcome measures encompass tooth survival, periodontal healing, and bone regeneration, whereas secondary outcomes evaluate patient-reported pain, functionality, and quality of life.

In this study, the comparator is the tooth's pre-treatment condition, which serves as the baseline for comparison. Given that the study used a pre-test, post-test interventional design, each tooth serves as its own control. Baseline examinations, encompassing clinical indicators (mobility, probing depth, gingival inflammation) and radiographic evaluation (bone level, periodontal ligament space, root resorption), are documented prior to intentional replantation. Subsequent to the intervention, these measures are reassessed at 9-month follow-up to evaluate treatment outcomes and alterations in alveolar bone. This comparison facilitates an impartial assessment of the efficacy of purposeful replantation in enhancing periodontal health and bone regeneration.

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Arab Emirates
    • Emirate of Fujairah
      • Fujairah, Emirate of Fujairah, United Arab Emirates, 2202
        • Recruiting
        • Dental Clinic, College of Dentistry, University of Fujairah,
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patients meeting the specified criteria will be included in the study.

  • The patients with American Society of Anesthesiologists physical status classification 1 and 2.
  • Radiographic bone loss of at least 50% around the targeted tooth.
  • Probing depth of at least 5 millimetres around the targeted tooth.
  • Grade III mobility (extreme mobility) of the targeted tooth according to Miller's classification.
  • Grade II mobility or less (minimal to slight increased mobility without functional impairment) of adjacent teeth.
  • Distance between the targeted tooth and adjacent teeth less than 2 millimetres.
  • Patient preference for tooth retention through intentional replantation over extraction.

Exclusion Criteria:

  • Previous history of failed IR.
  • Severe anatomical limitations in the treatment area.
  • Unwillingness to adhere to follow-up protocols

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intentional Replantation of Hopeless Periodontally Involved Single-Rooted Teeth

This study evaluates the outcomes of intentional replantation of hopeless periodontally involved single-rooted teeth using a pre-test, post-test interventional design.

At baseline, clinical and CBCT assessments will be performed to evaluate alveolar bone levels, periodontal status, and tooth mobility. The intervention involves atraumatic extraction, extraoral conditioning (if needed), and replantation with stabilization.

At 9 months, follow-up CBCT and clinical evaluations will assess bone changes, periodontal healing, and tooth stability.
Procedure: Intentional Replantation
The intervention involves intentional replantation (IR) of periodontally compromised single-rooted teeth. Patients are selected based on criteria ensuring no vertical root fractures and potential for restoration. Preoperative preparation includes radiographic evaluation (CBCT/periapical), scaling, and root planing, along with antibiotic prophylaxis. The tooth is extracted non-traumatically using periotomes to preserve the periodontal ligament (PDL). After extraction, the tooth is stored in a sterile medium and granulation tissue is excised. Optional modifications (apical resection, retrograde filling, or surface treatment) may be performed. The tooth is then replanted into the socket, secured with a non-rigid splint, and occlusal adjustment is made. Postoperative care includes analgesics, antibiotics, and chlorhexidine rinse. Follow-ups are scheduled at 1 week, 4 weeks, and 9 months for evaluation of healing, survival, and patient-reported outcomes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of IR procedure
Time Frame: Baseline and 9 months post-replantation

Definition: Success will be assessed based on clinical and radiographic outcomes at 9 months post-replantation.

Key indicators:

Preservation of alveolar bone levels (measured via CBCT and periapical radiographs).

Absence of significant root resorption. Re-establishment of periodontal ligament attachment around the replanted tooth. Unit of Measurement: Binary outcome (Success vs. Failure)
Baseline and 9 months post-replantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Level
Time Frame: Baseline and 9 months post-replantation

Definition: Pain level will be assessed using the Visual Analog Scale (VAS), which ranges from 0 (no pain) to 10 (unbearable pain).

Unit of Measurement: VAS score (0-10)
Baseline and 9 months post-replantation
Change in Tooth Mobility
Time Frame: Baseline and 9 months post-replantation
Definition: Tooth mobility will be measured using Miller's Mobility Criteria (Grade 0-3). Where 0 indicates No mobility. 3 indicates movement of more than 1 mm in horizontal direction with mobility in the vertical direction OR movement of more than 2 mm in Horizontal direction OR vertical mobility Unit of Measurement: Mobility grade (ordinal scale: 0-3)
Baseline and 9 months post-replantation
Change in Probing Depth (PD)
Time Frame: Baseline and 9 months post-replantation

Definition: Probing Depth will be measured using a WHO periodontal probe at four surfaces (mesial, distal, buccal, lingual).

Unit of Measurement: Probing Depth (millimeters, mm)
Baseline and 9 months post-replantation
Change in Bleeding on Probing (BOP)
Time Frame: Baseline and 9 months post-replantation
Definition: Bleeding on Probing (BOP) will be recorded as present or absent. Unit of Measurement: Bleeding on Probing (Binary: Present/Absent)
Baseline and 9 months post-replantation
Change in Alveolar Bone Loss Percentage (BL%)
Time Frame: Baseline and 9 months post-replantation

Definition: BL% will be calculated using the formula:

BL%= (L-Lr)/L ×100, where L = total root length, and Lr = remaining alveolar bone height.

Unit of Measurement: Percentage (%)
Baseline and 9 months post-replantation
Change in Oral Health-Related Quality of Life (OHRQoL)
Time Frame: Baseline and 9 months post-replantation

Definition: Assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire.

Unit of Measurement: OHIP-14 score (range: 0-56, higher scores indicate worse quality of life)
Baseline and 9 months post-replantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Fujairah

Investigators

  • Principal Investigator: Nabeel Ayappali Kalluvalappil, MDS, Lecturer, College of Dentistry, University of Fujairah, UAE, Zip Code 2202

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2024

Primary Completion (Actual)

July 1, 2025

Study Completion (Estimated)

March 15, 2026

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 20, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USTFREC2024-03-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share individual participant data (IPD) with other researchers. Data will only be used for analysis within the scope of this study and will not be publicly available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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