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

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-25

Study Completion Date

2026-03-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Periodontitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Intentional Replantation

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Fujairah

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nabeel Ayappali Kalluvalappil, MDS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dental Clinic, College of Dentistry, University of Fujairah,

Fujairah, Emirate of Fujairah, United Arab Emirates

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United Arab Emirates

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nabeel Ayappali Kalluvalappil, MDS

Role: CONTACT

+971504614791

Tamer Hamed Hassan, PhD

Role: CONTACT

+971902023500

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nabeel Ayappali Kalluvalappil, MDS

Role: primary

+971504614791

Tamer Hamed Hassan, PhD

Role: backup

+97192023500 ext. 501

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 37398781 (View on PubMed)

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.

Reference Type RESULT
PMID: 36611471 (View on PubMed)

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.

Reference Type RESULT
PMID: 32855480 (View on PubMed)

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.

Reference Type RESULT
PMID: 29033086 (View on PubMed)

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.

Reference Type RESULT
PMID: 29061358 (View on PubMed)

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.

Reference Type RESULT
PMID: 30529534 (View on PubMed)

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.

Reference Type RESULT
PMID: 28215343 (View on PubMed)

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.

Reference Type RESULT
PMID: 30684952 (View on PubMed)

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.

Reference Type RESULT
PMID: 31410671 (View on PubMed)

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.

Reference Type RESULT
PMID: 36676664 (View on PubMed)

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.

Reference Type DERIVED
PMID: 41085111 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

USTFREC2024-03-3

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.