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

NCT06893107 | Recruiting DMC

• 1 other identifier: USTFREC2024-03-3
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Periodontitis

Keywords

Chronic periodontitis; Periodontally compromised tooth; Intentional replantation

Outcome Measures

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)

  Baseline and 9 months post-replantation

Secondary Outcomes (6)

• Change in Pain Level

  Baseline and 9 months post-replantation

• Change in Tooth Mobility

  Baseline and 9 months post-replantation

• Change in Probing Depth (PD)

  Baseline and 9 months post-replantation

• Change in Bleeding on Probing (BOP)

  Baseline and 9 months post-replantation

• Change in Alveolar Bone Loss Percentage (BL%)

  Baseline and 9 months post-replantation

Study Arms (1)

Intentional Replantation of Hopeless Periodontally Involved Single-Rooted Teeth

EXPERIMENTAL

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

Interventions

Intentional Replantation PROCEDURE

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.

Intentional Replantation of Hopeless Periodontally Involved Single-Rooted Teeth

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Fujairah: lead

Study Sites (1)

Dental Clinic, College of Dentistry, University of Fujairah,

Fujairah, Emirate of Fujairah, 2202, United Arab Emirates

RECRUITING

Related Publications (11)

• 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.

  PMID: 37398781 RESULT

• 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.

  PMID: 36611471 RESULT

• 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.

  PMID: 32855480 RESULT

• 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.

  PMID: 29033086 RESULT

• 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.

  PMID: 29061358 RESULT

• 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.

  PMID: 30529534 RESULT

• 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.

  PMID: 28215343 RESULT

• 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.

  PMID: 30684952 RESULT

• 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.

  PMID: 31410671 RESULT

• 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.

  PMID: 36676664 RESULT

• 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.

  PMID: 41085111 DERIVED

MeSH Terms

Conditions

Chronic Periodontitis

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nabeel Ayappali Kalluvalappil, MDS

  Lecturer, College of Dentistry, University of Fujairah, UAE, Zip Code 2202

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabeel Ayappali Kalluvalappil, MDS

CONTACT

+971504614791; nabeelsabeel@gmail.com

Tamer Hamed Hassan, PhD

CONTACT

+971902023500; t.hassan@uof.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: March 25, 2025
• Study Start: March 25, 2024
• Primary Completion: July 1, 2025
• Study Completion: March 15, 2026
• Last Updated: November 26, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1)