Alveolar Bone Loss, Tooth Extraction
Conditions
Keywords
Dental implant, Tooth extraction, Alveolar ridge preservation, Guided Bone Regeneration, Bone regeneration, Dental Implant Placement
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREReduced 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.
PROCEDUREStandard time interval treatment protocol
Participants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice.
Sponsors
Universidad Catolica Santiago de Guayaquil
Klockner Implant System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age: ≥ 18 years. * Good general health. * Need of extraction of incisors, canines or premolars due to carious lesion, endodontic complication, root fracture or prosthetic reason. * Presence of three intact socket walls after tooth extraction with a defect of 50% or more of the buccal wall. * Need of single-tooth implant treatment, with presence of adjacent teeth and opposing occluding teeth (for measurement stent indexing). * Enough available bone assessed on CBCT to place implants with 3.6 mm diameter and 10 mm in length. * Periodontal health in intact or reduced periodontium. * Full-mouth plaque and bleeding scores \< 20%. * Able and willing to follow study procedures and instructions.
Exclusion criteria
* \< 18 years. * Compromised health. Existence of any systemic condition such as uncontrolled diabetes mellitus, cancer, HIV, disorders that compromise wound healing, chronic high dose steroid therapy, intravenous and oral bisphosphonate therapy, bone metabolic diseases, history of irradiation of the head and neck area, or any other immunosuppressive therapy that would contraindicate oral surgical treatment. * Absence of any adjacent teeth or the opposing occluding teeth. * The hopeless tooth is a molar.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT) | Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in vertical alveolar bone height (mm) measured by cone-beam computed tomography (CBCT) | Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement) | 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. |
| Mean implant stability quotient (ISQ) measured using resonance frequency analysis (Osstell IDx) | Implant placement to prosthetic loading (approximately 3 months) | 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. |
| Mean marginal bone level change (mm) measured on standardized periapical radiographs | Implant placement to 2 years after prosthetic loading | 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. |
| Mean postoperative pain score measured using the Visual Analog Scale (VAS, 0-10) | 24 hours to 14 days after implant placement surgery | 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. |
Countries
Ecuador
Contacts
CONTACTGABRIELA GUADALUPE ZAMBRANO MANZABA, DDS
Outcome results
None listed