Dental ImplantsNCT05722041
Soft Tissue Volume Changes in Posterior Socket Sealing Abutment.
A study testing Immediate dental implant placement in people with Dental Implants and Tooth Loss, run by Aula Dental Avanzada at 1 site in Spain.
Trial summary
The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dental Implants, Tooth Loss, Immediate Dental Implant Placement
- What is being tested?
- Immediate dental implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2022to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I or ASA II health status
- Age between 18 and 80 years
- Presence of a molar with poor restorative prognosis requiring extraction and immediate post-extraction implant placement
Who cannot join
- Psychiatric conditions or any condition preventing the patient from adequately completing the questionnaire
- Teeth with periodontal involvement and loss of attachment caused by root fracture
- Alveolus with bone deficiencies where an immediate implant cannot be adequately placed
- Medical conditions contraindicating dental implant placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Soft Tissue Volume Changes in the Posterior Area With Socket Sealing Abutment. Randomized Controlled Trial.
The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement.
Thirty patients in ASA I-II health status who require immediate post-extraction implant treatment in the molar area were recruited after giving their informed consent, and were randomly allocated to two parallel groups (customised abutment vs. conventional abutment). The randomisation list was generated with the List Randomizer tool (Random.org), and allocation was performed by a secretary external to the research team after implant placement.
Read more
The soft tissue status is recorded before and 6 months after treatment by means of a digital impression taken with the same intraoral scanner. The patient completes a 7-question questionnaire on their perception of the therapeutic process and the final result.
A comparative volume measurement is made by digitally superimposing the two mesh files obtained before and 6 months after treatment. Digital models are anonymised and measured by an independent outcome assessor blinded to group allocation. Statistical data are analysed by an external statistician.
Read the detailed description
Thirty patients in ASA I-II health status requiring immediate post-extraction implant treatment in the molar area were recruited after informed consent and randomly allocated to two parallel groups: an experimental group receiving a customised sealing abutment and a control group receiving a conventional abutment, both after immediate implant placement.
The randomisation list was generated with the List Randomizer tool (Random.org), and group allocation was performed by a secretary external to the research team after implant placement, ensuring allocation concealment.
Soft tissue status is recorded before and 6 months after treatment using a digital impression taken with the same intraoral scanner (Medit i700). Patients complete a 7-question questionnaire on their perception of the therapeutic process and outcome.
Volumetric change is measured by digitally superimposing the mesh files obtained before and 6 months after treatment. Digital models are anonymised and coded, and measured by an independent outcome assessor blinded to group allocation. Statistical analysis is performed by an external statistician.
- Being tested
- Immediate dental implant placement
- Keywords
- Dental implant, Immediate implants, Custom Abutment, Sealing Socket Abutment
- Medical subject headings
- Tooth Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implant placementProcedure or surgery
Also called Dental implant surgery
Placement of one dental implant immediately after tooth extraction.
| Study group | Role | What they receive |
|---|---|---|
| Customized Abutment | Experimental | Customized abutment will be placed after molar immediate implant placement. Receives: Procedure: Immediate dental implant placement |
| Conventional Abutment | Active comparator | Conventional abutment will be placed after molar immediate implant placement. Receives: Procedure: Immediate dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Soft tissue dimensional changes
The changes that occur in the soft tissues in millimetres by comparing the digital impressions before and 6 months after the treatment using specific software.
Measured: From 0 to 6 months
Secondary outcomes (1)
Patients satisfaction
Patients will be asked about their satisfaction after the treatment in a Numerical Rate Scale form 0 (Not satisfied) to 10 (Very satisfied).
Measured: From 0 to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Sep 2022
- Primary completion31 Dec 2025
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies 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
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aula Dental Avanzada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillem Esteve-Pardo, Aula Dental Avanzada
- Investigators
- Guillem Esteve-Pardo, PhD, Principal investigator, Clinica Dental Esteve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722041
- Sponsor's protocol ID
- CUSTOM
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2022
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sets obtained during the course of this study will be made available from the corresponding author upon reasonable request.
Publications
Tan 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 22211303Chu SJ, Salama MA, Garber DA, Salama H, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Reynolds MA, Saito H, Tarnow DP. Flapless Postextraction Socket Implant Placement, Part 2: The Effects of Bone Grafting and Provisional Restoration on Peri-implant Soft Tissue Height and Thickness- A Retrospective Study. Int J Periodontics Restorative Dent. 2015 Nov-Dec;35(6):803-9. doi: 10.11607/prd.2178.
PubMed 26509983Finelle G, Lee SJ. Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):e63-e67. doi: 10.11607/jomi.4770.
PubMed 28291855Ruales-Carrera E, Pauletto P, Apaza-Bedoya K, Volpato CAM, Ozcan M, Benfatti CAM. Peri-implant tissue management after immediate implant placement using a customized healing abutment. J Esthet Restor Dent. 2019 Nov;31(6):533-541. doi: 10.1111/jerd.12512. Epub 2019 Jul 3.
PubMed 31268244Conejo J, Atria PJ, Hirata R, Blatz MB. Copy milling to duplicate the emergence profile for implant-supported restorations. J Prosthet Dent. 2020 May;123(5):671-674. doi: 10.1016/j.prosdent.2019.05.035. Epub 2019 Oct 1.
PubMed 31582167Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.
PubMed 33438320Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.
PubMed 34551159Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.
PubMed 31797548Fernandes D, Nunes S, Lopez-Castro G, Marques T, Montero J, Borges T. Effect of customized healing abutments on the peri-implant linear and volumetric tissue changes at maxillary immediate implant sites: A 1-year prospective randomized clinical trial. Clin Implant Dent Relat Res. 2021 Oct;23(5):745-757. doi: 10.1111/cid.13044. Epub 2021 Aug 22.
PubMed 34423560
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Soft Tissue Volume Changes in the Posterior Area With Socket Sealing Abutment. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT05722041
- Acronym / sponsor ID
- CUSTOM
- Keywords
- Dental implant, Immediate implants, Custom Abutment, Sealing Socket Abutment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Aula Dental AvanzadaUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 10 Feb 2023 (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.
The aim is to clinically evaluate the effect of the alveolar sealing technique using a customised abutment on soft tissue volume changes following molar extraction and immediate dental implant placement.
Thirty patients in ASA I-II health status who require immediate post-extraction implant treatment in the molar area were recruited after giving their informed consent, and were randomly allocated to two parallel groups (customised abutment vs. conventional abutment). The randomisation list was generated with the List Randomizer tool (Random.org), and allocation was performed by a secretary external to the research team after implant placement.
The soft tissue status is recorded before and 6 months after treatment by means of a digital impression taken with the same intraoral scanner. The patient completes a 7-question questionnaire on their perception of the therapeutic process and the final result.
A comparative volume measurement is made by digitally superimposing the two mesh files obtained before and 6 months after treatment. Digital models are anonymised and measured by an independent outcome assessor blinded to group allocation. Statistical data are analysed by an external statistician.
Detailed description
Thirty patients in ASA I-II health status requiring immediate post-extraction implant treatment in the molar area were recruited after informed consent and randomly allocated to two parallel groups: an experimental group receiving a customised sealing abutment and a control group receiving a conventional abutment, both after immediate implant placement.
The randomisation list was generated with the List Randomizer tool (Random.org), and group allocation was performed by a secretary external to the research team after implant placement, ensuring allocation concealment.
Soft tissue status is recorded before and 6 months after treatment using a digital impression taken with the same intraoral scanner (Medit i700). Patients complete a 7-question questionnaire on their perception of the therapeutic process and outcome.
Volumetric change is measured by digitally superimposing the mesh files obtained before and 6 months after treatment. Digital models are anonymised and coded, and measured by an independent outcome assessor blinded to group allocation. Statistical analysis is performed by an external statistician.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Customized Abutment | Experimental | Procedure: Immediate dental implant placementCustomized abutment will be placed after molar immediate implant placement. |
| Conventional Abutment | Active comparator | Procedure: Immediate dental implant placementConventional abutment will be placed after molar immediate implant placement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I or ASA II health status
- Age between 18 and 80 years
- Presence of a molar with poor restorative prognosis requiring extraction and immediate post-extraction implant placement
Key exclusion criteria (4 listed)
- Psychiatric conditions or any condition preventing the patient from adequately completing the questionnaire
- Teeth with periodontal involvement and loss of attachment caused by root fracture
- Alveolus with bone deficiencies where an immediate implant cannot be adequately placed
- Medical conditions contraindicating dental implant placement
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 |
|---|---|---|
| Immediate dental implant placementAlso: Dental implant surgeryPlacement of one dental implant immediately after tooth extraction. | Procedure or surgery | Conventional Abutment, Customized Abutment |
Primary outcome
Soft tissue dimensional changes
Time frame: From 0 to 6 months
The changes that occur in the soft tissues in millimetres by comparing the digital impressions before and 6 months after the treatment using specific software.
1 secondary outcome
Patients satisfaction
Time frame: From 0 to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Results publication: 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.
- Results publication: PubMed 26509983Chu SJ, Salama MA, Garber DA, Salama H, Sarnachiaro GO, Sarnachiaro E, Gotta SL, Reynolds MA, Saito H, Tarnow DP. Flapless Postextraction Socket Implant Placement, Part 2: The Effects of Bone Grafting and Provisional Restoration on Peri-implant Soft Tissue Height and Thickness- A Retrospective Study. Int J Periodontics Restorative Dent. 2015 Nov-Dec;35(6):803-9. doi: 10.11607/prd.2178.
- Results publication: PubMed 28291855Finelle G, Lee SJ. Guided Immediate Implant Placement with Wound Closure by Computer-Aided Design/Computer-Assisted Manufacture Sealing Socket Abutment: Case Report. Int J Oral Maxillofac Implants. 2017 Mar/Apr;32(2):e63-e67. doi: 10.11607/jomi.4770.
- Results publication: PubMed 31268244Ruales-Carrera E, Pauletto P, Apaza-Bedoya K, Volpato CAM, Ozcan M, Benfatti CAM. Peri-implant tissue management after immediate implant placement using a customized healing abutment. J Esthet Restor Dent. 2019 Nov;31(6):533-541. doi: 10.1111/jerd.12512. Epub 2019 Jul 3.
- Results publication: PubMed 31582167Conejo J, Atria PJ, Hirata R, Blatz MB. Copy milling to duplicate the emergence profile for implant-supported restorations. J Prosthet Dent. 2020 May;123(5):671-674. doi: 10.1016/j.prosdent.2019.05.035. Epub 2019 Oct 1.
- Results publication: PubMed 33438320Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.
- Results publication: PubMed 34551159Lilet R, Desiron M, Finelle G, Lecloux G, Seidel L, Lambert F. Immediate implant placement combining socket seal abutment and peri-implant socket filling: A prospective case series. Clin Oral Implants Res. 2022 Jan;33(1):33-44. doi: 10.1111/clr.13852. Epub 2021 Oct 22.
- Results publication: PubMed 31797548Perez A, Caiazzo A, Valente NA, Toti P, Alfonsi F, Barone A. Standard vs customized healing abutments with simultaneous bone grafting for tissue changes around immediate implants. 1-year outcomes from a randomized clinical trial. Clin Implant Dent Relat Res. 2020 Feb;22(1):42-53. doi: 10.1111/cid.12871. Epub 2019 Dec 3.
- Results publication: PubMed 34423560Fernandes D, Nunes S, Lopez-Castro G, Marques T, Montero J, Borges T. Effect of customized healing abutments on the peri-implant linear and volumetric tissue changes at maxillary immediate implant sites: A 1-year prospective randomized clinical trial. Clin Implant Dent Relat Res. 2021 Oct;23(5):745-757. doi: 10.1111/cid.13044. Epub 2021 Aug 22.
- Individual participant dataSharing planned: Undecided. Data sets obtained during the course of this study will be made 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. This study is not recruiting at the moment.
Guillem Esteve-Pardo, PhD principal investigator
Clinica Dental Esteve
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate dental implant placement in people with Dental Implants and Tooth Loss, run by Aula Dental Avanzada 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 3 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: finished, as of the sponsor's last update on 17 Jul 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Soft tissue dimensional changes (time frame: From 0 to 6 months). 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 NCT05722041, which also lists 9 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 17 Jul 2026.