Dental ImplantNCT06764654
Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement
A study testing Dental implant placement in people with Dental Implant and Bone Resorption, run by Aula Dental Avanzada at 2 sites in Spain.
Trial summary
This is a randomized multicenter clinical study that compares two static guided surgery techniques in free-end partial edentulism. The aim is to compare the accuracy obtained between dento-osseous supported and dento-mucosal supported surgical splints to place dental implants in posterior osseous ridges. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant, Bone Resorption
- What is being tested?
- Dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jan 2025to 1 Mar 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
- Patients who present to one of the two participating clinics with a posterior edentulous area starting from the second premolar.
- Patients in whom the placement of dental implants is not contraindicated.
Who cannot join
- Patients with hypersensitivities or allergies that contraindicate the intervention.
- Presence of orofacial neurological symptoms.
- Patients treated with bisphosphonates.
- Pregnant or breastfeeding women, or women undergoing contraceptive treatment.
- Signs of infection in the surgical area.
- Need for unconventional surgical procedures (e.g., split crest, vertical regeneration, block graft).
- Lack of patient cooperation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain2 sites, 2 recruiting
- Recruiting
Clínica Dental Esteve
Alicante, Alicante, 03001
Guillem Esteve-Pardo, PhD, +34 965215755, guillem@clinicaesteve.es
Guillem Esteve-Pardo, PhD
- Recruiting
Clínica Dental Sánchez Nicolás
Cabezo de Torres, Murcia, 30110
Jose Antonio Sánchez-Nicolás, DDS, +34 968907578, josedentistacabezo@hotmail.com
Jose Antonio Sánchez-Nicolás, DDS
About this study
Official title: Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement: A Multicenter Study
This is a randomized multicenter clinical study that compares two static guided surgery techniques in free-end partial edentulism.
The aim is to compare the accuracy obtained between dento-osseous supported and dento-mucosal supported surgical splints to place dental implants in posterior osseous ridges.
Read the detailed description
Sample size increased from 20 to 40 participants (80 implants) via non-substantial amendment, acknowledged by the CEI Hospital Universitario Sant Joan d'Alacant (April 2026). Randomization and masking procedures unchanged.
- Conditions
- Dental Implant, Bone Resorption
- Being tested
- Dental implant placement
- Keywords
- dental implant, partial edentulous, guided surgery
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dental implant placementProcedure or surgery
Placement of two dental implants in the jaw.
| Study group | Role | What they receive |
|---|---|---|
| Tooth supported guide | Active comparator | Patients who will receive implant placement using a tooth supported surgical guide. Receives: Procedure: Dental implant placement |
| Bone and tooth supported guide | Experimental | Patients who will receive implant placement using a bone and tooth supported surgical guide. Receives: Procedure: Dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Three-dimensional implant position deviations (measured by intraoral scan and planning software)
Three-dimensional deviations between the planned implant position and the actual postoperative implant position will be assessed. The deviations will be measured using an intraoral scanner (Medit i700®) and planning software (BlueSky Plan®). Units of measure: horizontal and vertical linear deviation (in millimeters), global deviation (in millimeters), and angular deviation (in degrees), evaluated at both implant entry and apex points.
Measured: From enrollment to the end of surgery
Secondary outcomes (1)
Three-dimensional implant position deviations (measured by CBCT and planning software)
Three-dimensional deviations between the planned implant position and the actual postoperative implant position will be assessed. The deviations will be measured using cone-beam computed tomography (CBCT) and planning software (BlueSky Plan®). Units of measure: horizontal and vertical linear deviation (in millimeters), global deviation (in millimeters), and angular deviation (in degrees), evaluated at both implant entry and apex points.
Measured: From enrollment to the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantStudies 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
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Collaborators
- Mozo Grau Ticare
- Responsible party
- Principal investigator, Jose Antonio Sánchez-Nicolás, Aula Dental Avanzada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06764654
- Sponsor's protocol ID
- GUIDED
- Status last verified
- Oct 2026
- First submitted
- 2 Jan 2025
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data available from the corresponding author upon reasonable request
Publications
Lin CC, Ishikawa M, Maida T, Cheng HC, Ou KL, Nezu T, Endo K. Stereolithographic Surgical Guide with a Combination of Tooth and Bone Support: Accuracy of Guided Implant Surgery in Distal Extension Situation. J Clin Med. 2020 Mar 5;9(3):709. doi: 10.3390/jcm9030709.
PubMed 32151043Liu R, Xia R, Zhang L, Gan X, Li C, Liu Q, Chen Z, Chen Z. The influence of guide stabilizers and their application sequences on trueness and precision of surgical guides in free end situations: An in vitro analysis. Clin Oral Implants Res. 2024 Mar;35(3):294-304. doi: 10.1111/clr.14226. Epub 2023 Dec 19.
PubMed 38112164Kessler A, Le V, Folwaczny M. Influence of the tooth position, guided sleeve height, supporting length, manufacturing methods, and resin E-modulus on the in vitro accuracy of surgical implant guides in a free-end situation. Clin Oral Implants Res. 2021 Sep;32(9):1097-1104. doi: 10.1111/clr.13804. Epub 2021 Jul 17.
PubMed 34218450Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.
PubMed 37875645Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
PubMed 29608793Cho JY, Kim SB, Ryu J. The accuracy of a partially guided system using an in-office 3D-printed surgical guide for implant placement. Int J Comput Dent. 2021 Feb 26;24(1):19-27.
PubMed 34006060Raico Gallardo YN, da Silva-Olivio IRT, Mukai E, Morimoto S, Sesma N, Cordaro L. Accuracy comparison of guided surgery for dental implants according to the tissue of support: a systematic review and meta-analysis. Clin Oral Implants Res. 2017 May;28(5):602-612. doi: 10.1111/clr.12841. Epub 2016 Apr 8.
PubMed 27062555Bover-Ramos F, Vina-Almunia J, Cervera-Ballester J, Penarrocha-Diago M, Garcia-Mira B. Accuracy of Implant Placement with Computer-Guided Surgery: A Systematic Review and Meta-Analysis Comparing Cadaver, Clinical, and In Vitro Studies. Int J Oral Maxillofac Implants. 2018 January/February;33(1):101-115. doi: 10.11607/jomi.5556. Epub 2017 Jun 20.
PubMed 28632253
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Study Comparing Two Guided Surgery Techniques for Free-end Implant Placement: A Multicenter Study
- ClinicalTrials.gov ID
- NCT06764654
- Acronym / sponsor ID
- GUIDED
- Conditions
- Dental Implant, Bone Resorption
- Keywords
- dental implant, partial edentulous, guided surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Collaborators
- Mozo Grau Ticare
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Jan 2025 (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 is a randomized multicenter clinical study that compares two static guided surgery techniques in free-end partial edentulism.
The aim is to compare the accuracy obtained between dento-osseous supported and dento-mucosal supported surgical splints to place dental implants in posterior osseous ridges.
Detailed description
Sample size increased from 20 to 40 participants (80 implants) via non-substantial amendment, acknowledged by the CEI Hospital Universitario Sant Joan d'Alacant (April 2026). Randomization and masking procedures unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tooth supported guide | Active comparator | Procedure: Dental implant placementPatients who will receive implant placement using a tooth supported surgical guide. |
| Bone and tooth supported guide | Experimental | Procedure: Dental implant placementPatients who will receive implant placement using a bone and tooth supported surgical guide. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who present to one of the two participating clinics with a posterior edentulous area starting from the second premolar.
- Patients in whom the placement of dental implants is not contraindicated.
Key exclusion criteria (7 listed)
- Patients with hypersensitivities or allergies that contraindicate the intervention.
- Presence of orofacial neurological symptoms.
- Patients treated with bisphosphonates.
- Pregnant or breastfeeding women, or women undergoing contraceptive treatment.
- Signs of infection in the surgical area.
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 |
|---|---|---|
| Dental implant placementPlacement of two dental implants in the jaw. | Procedure or surgery | Bone and tooth supported guide, Tooth supported guide |
Primary outcome
Three-dimensional implant position deviations (measured by intraoral scan and planning software)
Time frame: From enrollment to the end of surgery
Three-dimensional deviations between the planned implant position and the actual postoperative implant position will be assessed. The deviations will be measured using an intraoral scanner (Medit i700®) and planning software (BlueSky Plan®). Units of measure: horizontal and vertical linear deviation (in millimeters), global deviation (in millimeters), and angular deviation (in degrees), evaluated at both implant entry and apex points.
1 secondary outcome
Three-dimensional implant position deviations (measured by CBCT and planning software)
Time frame: From enrollment to the end of 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 9 Oct 2026.
- Background: PubMed 32151043Lin CC, Ishikawa M, Maida T, Cheng HC, Ou KL, Nezu T, Endo K. Stereolithographic Surgical Guide with a Combination of Tooth and Bone Support: Accuracy of Guided Implant Surgery in Distal Extension Situation. J Clin Med. 2020 Mar 5;9(3):709. doi: 10.3390/jcm9030709.
- Background: PubMed 38112164Liu R, Xia R, Zhang L, Gan X, Li C, Liu Q, Chen Z, Chen Z. The influence of guide stabilizers and their application sequences on trueness and precision of surgical guides in free end situations: An in vitro analysis. Clin Oral Implants Res. 2024 Mar;35(3):294-304. doi: 10.1111/clr.14226. Epub 2023 Dec 19.
- Background: PubMed 34218450Kessler A, Le V, Folwaczny M. Influence of the tooth position, guided sleeve height, supporting length, manufacturing methods, and resin E-modulus on the in vitro accuracy of surgical implant guides in a free-end situation. Clin Oral Implants Res. 2021 Sep;32(9):1097-1104. doi: 10.1111/clr.13804. Epub 2021 Jul 17.
- Background: PubMed 37875645Shi Y, Wang J, Ma C, Shen J, Dong X, Lin D. A systematic review of the accuracy of digital surgical guides for dental implantation. Int J Implant Dent. 2023 Oct 25;9(1):38. doi: 10.1186/s40729-023-00507-w.
- Background: PubMed 29608793Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.
- Background: PubMed 34006060Cho JY, Kim SB, Ryu J. The accuracy of a partially guided system using an in-office 3D-printed surgical guide for implant placement. Int J Comput Dent. 2021 Feb 26;24(1):19-27.
- Background: PubMed 27062555Raico Gallardo YN, da Silva-Olivio IRT, Mukai E, Morimoto S, Sesma N, Cordaro L. Accuracy comparison of guided surgery for dental implants according to the tissue of support: a systematic review and meta-analysis. Clin Oral Implants Res. 2017 May;28(5):602-612. doi: 10.1111/clr.12841. Epub 2016 Apr 8.
- Background: PubMed 28632253Bover-Ramos F, Vina-Almunia J, Cervera-Ballester J, Penarrocha-Diago M, Garcia-Mira B. Accuracy of Implant Placement with Computer-Guided Surgery: A Systematic Review and Meta-Analysis Comparing Cadaver, Clinical, and In Vitro Studies. Int J Oral Maxillofac Implants. 2018 January/February;33(1):101-115. doi: 10.11607/jomi.5556. Epub 2017 Jun 20.
- Individual participant dataSharing planned: No. Data available from the corresponding author upon reasonable request
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dental implant placement in people with Dental Implant and Bone Resorption, run by Aula Dental Avanzada at 2 sites in Spain.
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 2 inclusion and 7 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 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Guillem Esteve-Pardo, PhD (+34 965215755, guillem@clinicaesteve.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Three-dimensional implant position deviations (measured by intraoral scan and planning software) (time frame: From enrollment to the end of surgery). 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 NCT06764654, which also lists 8 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 9 Oct 2026.