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Chronic PeriodontitisNCT06893107

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

A study testing Intentional Replantation in people with Chronic Periodontitis, run by University of Fujairah at 1 site in United Arab Emirates.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Periodontitis
What is being tested?
Intentional Replantation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteUnited Arab Emirates
Study dates
25 Mar 2024to 15 Mar 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United Arab Emirates1 site
  • Dental Clinic, College of Dentistry, University of Fujairah,

    Fujairah, Emirate of Fujairah, 2202

Other trials in United Arab Emirates

About this 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

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.

Read the 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.

Being tested
Intentional Replantation
Keywords
Chronic periodontitis, Periodontally compromised tooth, Intentional replantation
Medical subject headings
Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intentional ReplantationProcedure or surgery

    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.

Study groups in NCT06893107
Study groupRoleWhat they receive
Intentional Replantation of Hopeless Periodontally Involved Single-Rooted TeethExperimentalThis 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.
Receives: Procedure: Intentional Replantation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Baseline and 9 months post-replantation

Secondary outcomes (6)
  1. Change in Pain Level

    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)

    Measured: Baseline and 9 months post-replantation

  2. Change in Tooth Mobility

    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)

    Measured: Baseline and 9 months post-replantation

  3. Change in Probing Depth (PD)

    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)

    Measured: Baseline and 9 months post-replantation

  4. Change in Bleeding on Probing (BOP)

    Definition: Bleeding on Probing (BOP) will be recorded as present or absent. Unit of Measurement: Bleeding on Probing (Binary: Present/Absent)

    Measured: Baseline and 9 months post-replantation

  5. Change in Alveolar Bone Loss Percentage (BL%)

    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 (%)

    Measured: Baseline and 9 months post-replantation

  6. Change in Oral Health-Related Quality of Life (OHRQoL)

    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)

    Measured: Baseline and 9 months post-replantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2025
  2. Study start25 Mar 2024
  3. Primary completion1 Jul 2025
  4. Study completion15 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
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.
Masking
None (open label)
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06893107
Sponsor's protocol ID
USTFREC2024-03-3
Status last verified
Jul 2026
First submitted
11 Mar 2025
Last updated
21 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is no plan to share individual participant data (IPD) with other researchers. Data will only be used for analysis within the scope of this study and will not be publicly available.

Publications

  • 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.

    PubMed 37398781
  • 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.

    PubMed 36611471
  • 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.

    PubMed 32855480
  • 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.

    PubMed 29033086
  • 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.

    PubMed 29061358
  • 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.

    PubMed 30529534
  • 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.

    PubMed 28215343
  • 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.

    PubMed 30684952
  • 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.

    PubMed 31410671
  • 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.

    PubMed 36676664
  • 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.

    PubMed 41085111

Questions about this trial

What is this clinical trial studying?

A study testing Intentional Replantation in people with Chronic Periodontitis, run by University of Fujairah at 1 site in United Arab Emirates.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Success of IR procedure (time frame: Baseline and 9 months post-replantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06893107, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.

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