Clinical trial NCT06893107: Study on Treatment Results and Bone Changes After Replanting Severely Affected Teeth - a Before-and-After Study.
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis
Periodontally compromised tooth
Intentional replantation
Lead sponsor: University of Fujairah
Sponsor class: OTHER
First posted: 2025-03-25
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study follows a single-group assignment model where all participants undergo intentional replantation of hopeless periodontally involved single-rooted teeth. It uses a pre-test, post-test design, with assessments at two time points. At baseline, CBCT and clinical exams assess alveolar bone levels, periapical status, and periodontal condition. The intervention involves careful extraction, conditioning, replantation, and stabilization of the tooth. A follow-up CBCT scan at 9 months evaluates changes in alveolar bone levels, root resorption, and periodontal healing. Clinical evaluations assess tooth stability, periodontal health, and patient-reported outcomes. Key outcomes include bone height, resorption, and periodontal healing.
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Success of IR procedure
timeFrame: Baseline and 9 months post-replantation
Secondary outcomes:
measure: Change in Pain Level
timeFrame: Baseline and 9 months post-replantation
measure: Change in Tooth Mobility
timeFrame: Baseline and 9 months post-replantation
measure: Change in Probing Depth (PD)
timeFrame: Baseline and 9 months post-replantation
measure: Change in Bleeding on Probing (BOP)
timeFrame: Baseline and 9 months post-replantation
measure: Change in Alveolar Bone Loss Percentage (BL%)
timeFrame: Baseline and 9 months post-replantation
measure: Change in Oral Health-Related Quality of Life (OHRQoL)
timeFrame: Baseline and 9 months post-replantation
Other outcomes:
Locations:
city: Fujairah
country: United Arab Emirates
facility: Dental Clinic, College of Dentistry, University of Fujairah,
Study officials:
affiliation: Lecturer, College of Dentistry, University of Fujairah, UAE, Zip Code 2202
name: Nabeel Ayappali Kalluvalappil, MDS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Cho SY, Lee SJ, Kim E. Clinical Outcomes after Intentional Replantation of Periodontally Involved Teeth. J Endod. 2017 Apr;43(4):550-555. doi: 10.1016/j.joen.2016.11.024. Epub 2017 Feb 16.
citation: Wang L, Jiang H, Bai Y, Luo Q, Wu H, Liu H. Clinical outcomes after intentional replantation of permanent teeth: A systematic review. Bosn J Basic Med Sci. 2020 Feb 5;20(1):13-20. doi: 10.17305/bjbms.2019.3937.
citation: Zhang J, Luo N, Miao D, Ying X, Chen Y. Intentional replantation of periodontally involved hopeless teeth: a case series study. Clin Oral Investig. 2020 May;24(5):1769-1777. doi: 10.1007/s00784-019-03039-z. Epub 2019 Aug 13.
citation: Park SH, Paek SH, Kim B, Lee JT. Assessment of Bone Height Changes Based on the Cone-Beam Computed Tomography Following Intentional Replantation for Periodontally Compromised Teeth. Medicina (Kaunas). 2022 Dec 25;59(1):40. doi: 10.3390/medicina59010040.