Dental Clinic, College of Dentistry, University of Fujairah,
Fujairah, Emirate of Fujairah, 2202, United Arab Emirates
NCT Number: NCT06893107
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.
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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Fujairah, Emirate of Fujairah, 2202, United Arab Emirates
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patients meeting the specified criteria will be included in the study.
Exclusion criteria
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.
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)
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)
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)
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)
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)
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 (%)
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)
University of Fujairah
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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