Study on Treatment Results and Bone Changes After Replanting Severely Affected Teeth - A Before-and-After Study.
NCT ID: NCT06893107
Last Updated: 2025-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
45 participants
INTERVENTIONAL
2024-03-25
2026-03-15
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Severe anatomical limitations in the treatment area.
* Unwillingness to adhere to follow-up protocols
18 Years
70 Years
ALL
Yes
Sponsors
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University of Fujairah
OTHER
Responsible Party
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Principal Investigators
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Nabeel Ayappali Kalluvalappil, MDS
Role: PRINCIPAL_INVESTIGATOR
Lecturer, College of Dentistry, University of Fujairah, UAE, Zip Code 2202
Locations
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Dental Clinic, College of Dentistry, University of Fujairah,
Fujairah, Emirate of Fujairah, United Arab Emirates
Countries
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Central Contacts
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Facility Contacts
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References
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Praveen Kumar V, Sadasiva K, Raj Kumar J, Ramachandran A, Parthasarathy R, Thanikachalam Y. Current Trends in Intentional Replantation Treatment Among Endodontists and Postgraduate Students in India, the United States of America, and the United Kingdom: A Cross-Sectional Study. Cureus. 2023 May 30;15(5):e39742. doi: 10.7759/cureus.39742. eCollection 2023 May.
Pisano M, Di Spirito F, Martina S, Sangiovanni G, D'Ambrosio F, Iandolo A. Intentional Replantation of Single-Rooted and Multi-Rooted Teeth: A Systematic Review. Healthcare (Basel). 2022 Dec 21;11(1):11. doi: 10.3390/healthcare11010011.
Cunliffe J, Ayub K, Darcey J, Foster-Thomas E. Intentional replantation - a clinical review of cases undertaken at a major UK dental school. Br Dent J. 2020 Aug;229(4):230-238. doi: 10.1038/s41415-020-1988-6.
Becker BD. Intentional Replantation Techniques: A Critical Review. J Endod. 2018 Jan;44(1):14-21. doi: 10.1016/j.joen.2017.08.002. Epub 2017 Oct 21.
Mainkar A. A Systematic Review of the Survival of Teeth Intentionally Replanted with a Modern Technique and Cost-effectiveness Compared with Single-tooth Implants. J Endod. 2017 Dec;43(12):1963-1968. doi: 10.1016/j.joen.2017.08.019. Epub 2017 Oct 20.
Asgary S, Talebzadeh B. Intentional replantation of a molar with several endodontic complications. J Stomatol Oral Maxillofac Surg. 2019 Nov;120(5):489-492. doi: 10.1016/j.jormas.2018.11.019. Epub 2018 Dec 7.
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.
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.
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.
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.
Ayappali Kalluvalappil N, Kumar RS, Hassan TH. Intentional replantation of periodontally compromised teeth with concentrated growth factors. Clin Adv Periodontics. 2025 Oct 14. doi: 10.1002/cap.70017. Online ahead of print.
Other Identifiers
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USTFREC2024-03-3
Identifier Type: -
Identifier Source: org_study_id
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