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| Name | Class |
|---|---|
| Klockner Implant System | UNKNOWN |
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This randomized controlled clinical trial aims to evaluate whether reducing the healing interval for implant placement after extraction socket preservation improves clinical and radiographic outcomes compared with the conventional waiting period. Participants requiring single-tooth extraction and implant therapy will be randomly assigned to implant placement either 4 months or 6 months after ridge preservation using the Vega Plus implant system (Klockner).
Clinical and radiographic assessments will be performed at baseline and during follow-up visits. The primary outcome will be the mean change in horizontal alveolar ridge width measured using cone-beam computed tomography (CBCT). Secondary outcomes will include vertical bone height changes measured on CBCT, implant stability measured using resonance frequency analysis (ISQ values), marginal bone level changes assessed on standardized periapical radiographs, and postoperative pain assessed using the Visual Analog Scale (VAS).
The results of this study may contribute to optimizing treatment timing and improving efficiency in implant dentistry while maintaining favorable clinical outcomes.
The optimal interval between treatment phases remains uncertain in several clinical settings. Traditional protocols often include a waiting period between phases to allow tissue healing or stabilization; however, prolonged intervals may extend overall treatment time and potentially affect patient adherence and outcomes. Emerging evidence suggests that reducing the interval between phases could maintain clinical effectiveness while improving efficiency and patient satisfaction. This randomized controlled trial will compare a reduced-interval protocol with a conventional-interval protocol. Eligible participants who require multi-phase treatment will be randomized into two groups: (1) reduced-interval treatment and (2) standard-interval treatment. Clinical examinations will be conducted at baseline and at scheduled follow-up visits according to the study protocol.
Primary outcomes will assess clinically relevant parameters associated with the treated condition. Secondary outcomes will evaluate treatment duration, patient-reported symptoms, and quality-of-life measures. Statistical analyses will compare outcomes between groups to determine whether the reduced-interval approach provides equivalent or improved results compared with the conventional schedule.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced time Interval treatment protocol | Experimental | Participants receive implant placement after extraction socket preservation using a reduced healing interval according to the experimental protocol. |
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| Standard Time Interval | Active Comparator | Participants receive treatment following the conventional interval protocol used in routine clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduced time interval treatment protocol | Procedure | Participants receive treatment phases with a reduced time interval between sessions according to the experimental protocol in order to evaluate whether shortening the interval improves clinical outcomes and treatment efficiency. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT) | Horizontal alveolar ridge width will be measured in millimeters using cone-beam computed tomography (CBCT). Measurements will be obtained at three standardized levels (1 mm, 3 mm, and 5 mm below the crestal bone). Baseline and follow-up CBCT scans will be superimposed, and the mean change in ridge width (mm) between time points will be calculated. | Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement) |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in vertical alveolar bone height (mm) measured by cone-beam computed tomography (CBCT) | Vertical alveolar bone height will be measured in millimeters using CBCT by determining the distance between the crestal bone (line C) and the apical reference line (line A). Baseline and follow-up CBCT scans will be superimposed, and the mean change in vertical bone height will be calculated. | Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS | Contact | +19546298543 | gabriela.manzaba30@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad Catolica Santiago de Guayaquil- Carrera de Odontologia de La Ucsg | Recruiting | Guayaquil | Guayas | 090101 | Ecuador |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Brånemark PI, Zarb GA, Albrektsson T. Tissue-integrated prostheses: osseointegration in clinical dentistry. Quintessence Publishing; 1985. | ||
| 31620265 | Background | Juodzbalys G, Stumbras A, Goyushov S, Duruel O, Tozum TF. Morphological Classification of Extraction Sockets and Clinical Decision Tree for Socket Preservation/Augmentation after Tooth Extraction: a Systematic Review. J Oral Maxillofac Res. 2019 Sep 5;10(3):e3. doi: 10.5037/jomr.2019.10303. eCollection 2019 Jul-Sep. | |
| 23163915 |
| Label | URL |
|---|---|
| Institutional website of Universidad Católica de Santiago de Guayaquil where the study is conducted. | View source |
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De-identified individual participant data (IPD) that underlie the results reported in publications will be shared with qualified researchers upon reasonable request after publication of the study results.
Data will be available beginning 6 months after publication of the study results and will remain available for up to 5 years.
Researchers who provide a methodologically sound proposal may request access to the de-identified data. Requests should be directed to the principal investigator. Data will be shared for purposes of scientific research and meta-analysis.
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Participants will be randomly assigned to two parallel groups: one group receiving treatment with a reduced time interval between phases and a control group receiving treatment according to the conventional interval protocol. Outcomes will be compared between groups.
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| Standard time interval treatment protocol | Procedure | Participants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice. |
|
| Mean implant stability quotient (ISQ) measured using resonance frequency analysis (Osstell IDx) | Implant stability will be measured using resonance frequency analysis with the Osstell IDx device. Implant Stability Quotient (ISQ) values will be recorded in mesiodistal and buccolingual directions, and the mean ISQ value will be calculated for each implant. | Implant placement to prosthetic loading (approximately 3 months) |
| Mean marginal bone level change (mm) measured on standardized periapical radiographs | Marginal bone levels will be measured using standardized digital periapical radiographs obtained with a parallel technique and individualized film holders. The distance from the implant-abutment junction to the first bone-to-implant contact will be measured mesially and distally, and the mean marginal bone level change will be calculated. | Implant placement to 2 years after prosthetic loading |
| Mean postoperative pain score measured using the Visual Analog Scale (VAS, 0-10) | Postoperative pain will be assessed using the Visual Analog Scale ranging from 0 (no pain) to 10 (worst imaginable pain). The mean pain score will be calculated. | 24 hours to 14 days after implant placement surgery |
| Background |
| Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19. |
| 25867983 | Background | Araujo MG, Silva CO, Misawa M, Sukekava F. Alveolar socket healing: what can we learn? Periodontol 2000. 2015 Jun;68(1):122-34. doi: 10.1111/prd.12082. |
| 22211307 | Background | Hammerle CH, Araujo MG, Simion M; Osteology Consensus Group 2011. Evidence-based knowledge on the biology and treatment of extraction sockets. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:80-2. doi: 10.1111/j.1600-0501.2011.02370.x. |
| 22211303 | Background | Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x. |
| ID | Term |
|---|---|
| D016301 | Alveolar Bone Loss |
| ID | Term |
|---|---|
| D001862 | Bone Resorption |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D055093 | Periodontal Atrophy |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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