Alveolar Bone LossRIP-VEGANCT07484685
Reduced Time Interval for Implant Placement After Extraction Socket Preservation Using the Vega Plus Implants
A study testing Reduced time interval treatment protocol and Standard time interval treatment protocol in people with Alveolar Bone Loss and Tooth Extraction, run by Universidad Catolica Santiago de Guayaquil at 1 site in Ecuador.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Bone Loss, Tooth Extraction
- What is being tested?
- Reduced time interval treatment protocol and Standard time interval treatment protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEcuador
- Study dates
- 28 Feb 2026to 27 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- Periodontal health in intact or reduced periodontium.
- Full-mouth plaque and bleeding scores < 20%.
- Able and willing to follow study procedures and instructions.
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ecuador1 site, 1 recruiting
- Recruiting
Universidad Catolica Santiago de Guayaquil- Carrera de Odontologia de La Ucsg
Guayaquil, Guayas, 090101
GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS, +1 9546298543, gabriela.manzaba30@gmail.com
GABRIELA ZAMBRANO MANZABA, DDS, 9546298543, gabriela.manzaba30@gmail.com
About this study
Official title: Effect of Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using the Vega Plus Implant System (Klockner): A Randomized Controlled Clinical Trial
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.
Read the 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.
- Conditions
- Alveolar Bone Loss, Tooth Extraction
- Being tested
- Reduced time interval treatment protocol, Standard time interval treatment protocol
- Keywords
- Dental implant, Tooth extraction, Alveolar ridge preservation, Guided Bone Regeneration, Bone regeneration, Dental Implant Placement
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced time interval treatment protocolProcedure or surgery
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.
Standard time interval treatment protocolProcedure or surgery
Participants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Reduced time Interval treatment protocol | Experimental | Participants receive implant placement after extraction socket preservation using a reduced healing interval according to the experimental protocol. Receives: Procedure: Reduced time interval treatment protocol |
| Standard Time Interval | Active comparator | Participants receive treatment following the conventional interval protocol used in routine clinical practice. Receives: Procedure: Standard time interval treatment protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 hours to 14 days after implant placement surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2026
- Study start28 Feb 2026
- Primary completion30 Dec 2026 (estimated)
- Study completion27 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Catolica Santiago de Guayaquil
- Sponsor type
- University, hospital or other
- Collaborators
- Klockner Implant System S.A.
- Responsible party
- Principal investigator, Gabriela Guadalupe Zambrano Manzaba, Universidad Catolica Santiago de Guayaquil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07484685
- Sponsor's protocol ID
- 1728937721
- Acronym
- RIP-VEGA
- Status last verified
- Apr 2026
- First submitted
- 12 Mar 2026
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Brånemark PI, Zarb GA, Albrektsson T. Tissue-integrated prostheses: osseointegration in clinical dentistry. Quintessence Publishing; 1985.
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.
PubMed 31620265Jung 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.
PubMed 23163915Araujo 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.
PubMed 25867983Hammerle 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.
PubMed 22211307Tan 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.
PubMed 22211303
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Reducing the Time Interval for Implant Placement After Extraction Socket Preservation Using the Vega Plus Implant System (Klockner): A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07484685
- Acronym / sponsor ID
- RIP-VEGA / 1728937721
- Conditions
- Alveolar Bone Loss, Tooth Extraction
- Keywords
- Dental implant, Tooth extraction, Alveolar ridge preservation, Guided Bone Regeneration, Bone regeneration, Dental Implant Placement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidad Catolica Santiago de GuayaquilUniversity, hospital or other
- Collaborators
- Klockner Implant System S.A.
- Study start
- 28 Feb 2026 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 27 Feb 2027 (estimated)
- First posted
- 20 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Reduced time Interval treatment protocol | Experimental | Procedure: Reduced time interval treatment protocolParticipants receive implant placement after extraction socket preservation using a reduced healing interval according to the experimental protocol. |
| Standard Time Interval | Active comparator | Procedure: Standard time interval treatment protocolParticipants receive treatment following the conventional interval protocol used in routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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).
Key exclusion criteria (4 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced time interval treatment protocolParticipants 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. | Procedure or surgery | Reduced time Interval treatment protocol |
| Standard time interval treatment protocolParticipants receive implant placement after extraction socket preservation following the conventional healing interval used in routine clinical practice. | Procedure or surgery | Standard Time Interval |
Primary outcome
Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT)
Time frame: 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.
4 secondary outcomes
Mean change in vertical alveolar bone height (mm) measured by cone-beam computed tomography (CBCT)
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)
Time frame: Implant placement to prosthetic loading (approximately 3 months)
Mean marginal bone level change (mm) measured on standardized periapical radiographs
Time frame: Implant placement to 2 years after prosthetic loading
Mean postoperative pain score measured using the Visual Analog Scale (VAS, 0-10)
Time frame: 24 hours to 14 days after implant placement surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- BackgroundBrånemark PI, Zarb GA, Albrektsson T. Tissue-integrated prostheses: osseointegration in clinical dentistry. Quintessence Publishing; 1985.
- Background: PubMed 31620265Juodzbalys 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.
- Background: PubMed 23163915Jung 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.
- Background: PubMed 25867983Araujo 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.
- Background: PubMed 22211307Hammerle 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.
- Background: PubMed 22211303Tan 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.
- Institutional website of Universidad Católica de Santiago de Guayaquil where the study is conducted.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced time interval treatment protocol and Standard time interval treatment protocol in people with Alveolar Bone Loss and Tooth Extraction, run by Universidad Catolica Santiago de Guayaquil at 1 site in Ecuador.
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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 1 May 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 Ecuador. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact GABRIELA GUADALUPE ZAMBRANO MANZABA, DDS (+19546298543, gabriela.manzaba30@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change in horizontal alveolar ridge width (mm) measured by cone-beam computed tomography (CBCT) (time frame: Baseline (immediately after ridge preservation surgery) to 6 months after surgery (prior to implant placement)). 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 NCT07484685, which also lists 6 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 1 May 2026.