An interventional study of Reduced time interval treatment protocol and Standard time interval treatment protocol in Alveolar Bone Loss and Tooth Extraction, sponsored by Universidad Catolica Santiago de Guayaquil. Recruiting at 1 site in Ecuador. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by Universidad Catolica Santiago de Guayaquil · Not applicable, Interventional, and Treatment
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.
318 studies on the registry are indexed under Alveolar Bone Loss; 79 are open to participants now.
This study's planned enrollment of 40 is above the median of 25 across 269 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Universidad Catolica Santiago de Guayaquil is the lead sponsor of 4 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive implant placement after extraction socket preservation using a reduced healing interval according to the experimental protocol.
Procedure: Reduced time interval treatment protocol
Participants receive treatment following the conventional interval protocol used in routine clinical practice.
Procedure: Standard time interval treatment protocol
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.
Participants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice.
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.
Time frame: Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)
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.
Time frame: Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)
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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours to 14 days after implant placement surgery
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data will be available beginning 6 months after publication of the study results and will remain available for up to 5 years.
Access criteria: 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.
Started Feb 2026 (actual). Primary completion is estimated for Dec 2026, 10 months after the start.
Of 167 non-industry interventional studies with no phase under Alveolar Bone Loss, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 10 months is below that.
Counting every sponsor, half of 167 studies reached it within 18 months; a quarter within 11 and three quarters within 30.
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Universidad Catolica Santiago de Guayaquil