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Tooth ExtractionPhase 3NCT07047131

Resorbable vs Non-resorbable Bone Substitute at Immediate Post-extractive Single Implants

A Phase 3 study testing GTO® (fully resorbable bone substitute) and Apatos® (partially resorbable bone substitute) in people with Tooth Extraction and Bone Graft, run by Marco Esposito at 1 site in Spain.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This study compares two bone graft materials used when placing a dental implant right after tooth removal. One graft fully dissolves (GTO®), the other only partly (Apatos®). The goal is to see which one better preserves bone and improves appearance around the implant. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Tooth Extraction, Bone Graft, Alveolar Bone Loss
What is being tested?
GTO® (fully resorbable bone substitute) and Apatos® (partially resorbable bone substitute)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteSpain
Study dates
18 Dec 2018to 20 Dec 2030
Phase
Phase 3
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

  • Any patient requiring at least one single immediate post-extractive implant.
  • At least 18 year old, able to understand and to sign an informed consent
  • There must be sufficient bone to allow the placement of at least a 3.5 mm diameter and 8.5 mm long implant.
  • After tooth extraction there must be a potential gap of at least 2 mm from the buccal inner bone plate and the implant surface.

Who cannot join

  • General contraindications to implant surgery.
  • Immunosuppressed or immunocompromised patients.
  • Patients irradiated in the head and/or neck.
  • Uncontrolled diabetes.
  • Pregnancy or lactation.
  • Active periodontal disease
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  • Poor oral hygiene and motivation.
  • Addiction to alcohol or drugs.
  • Psychiatric problems and/or unrealistic expectations
  • Patients with an acute infection (abscess) in the site intended for implant placement.
  • Patients unable to commit to a 5-year follow-up.
  • Patients treated or under treatment with intravenous amino-bisphosphonates.
  • patients referred only for implant placement if follow-ups cannot be done at treatment centre.
  • Patients participating in other studies, if the present protocol could not be fully adhered to. In case of doubts please contact the study coordinator.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • King Juan Carlos University

    Madrid, Madrid, 28933

Other trials in Spain

About this study

Official title: A Resorbable Versus a Non-resorbable Bone Substitute at Immediate Post-extractive Single Implants Immediately Loaded: a Multicentre Randomised Controlled Trial

This study compares two bone graft materials used when placing a dental implant right after tooth removal. One graft fully dissolves (GTO®), the other only partly (Apatos®).

The goal is to see which one better preserves bone and improves appearance around the implant.

Read the detailed description

This multicenter, double-blind randomized controlled trial aims to compare the clinical, radiographic, and aesthetic outcomes of two xenogeneic bone substitutes, GTO® (fully resorbable) and Apatos® (partially resorbable), used in post-extractive sockets at the time of immediate implant placement.

Eligible patients are adults requiring a single-tooth extraction in the maxilla or mandible, followed by immediate implant placement.

The primary outcome is peri-implant bone volume changes over time, assessed using CBCT scans.

Secondary outcomes include implant and crown failure, implant stability, marginal bone level changes on periapical radiographs, and aesthetic outcomes evaluated using the pink esthetic score based on clinical photographs.

Patients will be followed up to 5 years after loading.

Being tested
GTO® (fully resorbable bone substitute), Apatos® (partially resorbable bone substitute)
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.

  • GTO® (fully resorbable bone substitute)Biological

    Collagenated heterologous cortico-cancellous porcine bone mix + thermogelling copolymer with collagen (GTO®, OsteoBiol®, Tecnoss®)

  • Apatos® (partially resorbable bone substitute)Biological

    Porcine cortical bone granules (Apatos Cortical®, OsteoBiol®, Tecnoss®) stabilized with TSV Gel®, a thermogelling copolymer with collagen.

Study groups in NCT07047131
Study groupRoleWhat they receive
Resorbable Bone Substitute (GTO®)ExperimentalPatients receive a fully resorbable bone substitute (GTO®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement.
Receives: Biological: GTO® (fully resorbable bone substitute)
Partially Resorbable Bone Substitute (Apatos®)Active comparatorPatients receive a partially resorbable bone substitute (Apatos®) to fill the gap between the implant and the buccal bone wall during immediate post-extraction implant placement.
Receives: Biological: Apatos® (partially resorbable bone substitute)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes in peri-implant bone volumes

    Volumetric changes in peri-implant tissues will be measured using limited-view CBCT scans taken at implant placement (baseline), 1 year, and 5 years after loading. The main endpoint is the difference in bone volume between baseline and 1 year.

    Measured: From enrollment to 5 years after implant loading

Secondary outcomes (4)

  1. Number of participants with crown or implant failure

    Defined as the inability to place the crown due to implant failure, or the need for crown replacement for any reason. Implant failure is defined as implant mobility and/or any infection dictating implant removal and any mechanical complications rendering the implant unusable (e.g. implant fracture). The stability of each individual implant will be measured by the blinded outcome assessor manually by assessing the stability of the crown using the handles of two metallic instruments at 1 and 5 years after loading.

    Measured: From enrollment to 5 years after implant loading

  2. Number of biological and biomechanical complications

    Biological and biomechanical complications will be recorded and reported by study group. Examples of biological complications are: fistula, peri-implantitis. Examples of biomechanical complications are fracture of the metal screws, loosening of the crown, fracture of the ceramic lining.

    Measured: From enrollment to 5 years after implant loading

  3. Peri-implant marginal bone level changes

    Periapical digital radiographs will be made with the paralleling technique at implant placement, at 1 and 5 years of loading. In case of an unreadable radiograph, the radiograph must be made again. Peri-implant marginal bone levels will be measured using the Image J (National Institutes of Health, Bethesda, Maryland, USA) software. The software will be calibrated for every single image using the known implant length or, if the full implants is not visible on the radiograph, the implant diameter. Measurements of the mesial and distal bone crest level adjacent to each implant will be made to the nearest 0.01 mm. Reference points for the linear measurements will be: the coronal margin of the implant collar and the most coronal point of bone-to-implant contact. Bone levels will be measured at both mesial and distal sides and averaged. Bone level at single implants will be averaged at group level.

    Measured: From enrollment to 5 years after implant loading

  4. Aesthetic evaluation using the Pink Esthetic Score (0-14; higher scores = better outcome)

    Aesthetic evaluation of the clinical pictures taken at delivery of the final crown (baseline), at 1- and 5-year follow-ups, on a computer screen by an independent blinded dentist. The pictures of the vestibular and occlusal aspects must include the two adjacent teeth. The aesthetic evaluation will be done following thePink Esthetic Score, a validated index that ranges from 0 (worst aesthetic outcome) to 14 (best aesthetic outcome), based on soft tissue parameters around the implant implant-supported crown.

    Measured: From enrollment to 5 years after implant loading

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2025
  2. Study start18 Dec 2018
  3. Primary completion20 Dec 2025 (estimated)
  4. Study completion20 Dec 2030 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07047131
Sponsor's protocol ID
2301201902319
Status last verified
Jul 2025
First submitted
24 Jun 2025
Last updated
4 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Furhauser R, Florescu D, Benesch T, Haas R, Mailath G, Watzek G. Evaluation of soft tissue around single-tooth implant crowns: the pink esthetic score. Clin Oral Implants Res. 2005 Dec;16(6):639-44. doi: 10.1111/j.1600-0501.2005.01193.x.

    PubMed 16307569

  • Thalmair T, Fickl S, Schneider D, Hinze M, Wachtel H. Dimensional alterations of extraction sites after different alveolar ridge preservation techniques - a volumetric study. J Clin Periodontol. 2013 Jul;40(7):721-7. doi: 10.1111/jcpe.12111. Epub 2013 May 5.

    PubMed 23647007

  • De Angelis N, Felice P, Pellegrino G, Camurati A, Gambino P, Esposito M. Guided bone regeneration with and without a bone substitute at single post-extractive implants: 1-year post-loading results from a pragmatic multicentre randomised controlled trial. Eur J Oral Implantol. 2011 Winter;4(4):313-25.

    PubMed 22282729

  • Esposito M, Grusovin MG, Polyzos IP, Felice P, Worthington HV. Interventions for replacing missing teeth: dental implants in fresh extraction sockets (immediate, immediate-delayed and delayed implants). Cochrane Database Syst Rev. 2010 Sep 8;2010(9):CD005968. doi: 10.1002/14651858.CD005968.pub3.

    PubMed 20824846

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GTO® (fully resorbable bone substitute) and Apatos® (partially resorbable bone substitute) in people with Tooth Extraction and Bone Graft, run by Marco Esposito at 1 site 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 4 inclusion and 14 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: under way, not looking for participants, as of the sponsor's last update on 4 Jul 2025. 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 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in peri-implant bone volumes (time frame: From enrollment to 5 years after implant loading). 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 NCT07047131, which also lists 4 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 4 Jul 2025.

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