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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUniversity of Fujairah

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Previous history of failed IR.

Severe anatomical limitations in the treatment area.

Unwillingness to adhere to follow-up protocols

Trial design

Design model

Single group

Treatments tested in this trial

  • Intentional Replantation

    Procedure/Surgery

    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.

Treatment groups

45 Participants
are divided into 1 treatment group
Group A: Intentional Replantation of Hopeless Periodontally Involved Single-Rooted TeethExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Success of IR procedure

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)

Time frame
Baseline and 9 months post-replantation

Secondary outcomes

1

Change in Pain Level

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)

Time frame
Baseline and 9 months post-replantation
2

Change in Tooth Mobility

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)

Time frame
Baseline and 9 months post-replantation
3

Change in Probing Depth (PD)

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)

Time frame
Baseline and 9 months post-replantation
4

Change in Bleeding on Probing (BOP)

Definition: Bleeding on Probing (BOP) will be recorded as present or absent. Unit of Measurement: Bleeding on Probing (Binary: Present/Absent)

Time frame
Baseline and 9 months post-replantation

Other outcomes

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