Dental ImplantNCT05663385
Mucograft Seal in ARP Follow-up
An observational study of Dental Implant, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Early implant placement with alveolar ridge preservation (ARP) using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP, up to 1 year after functional loading. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implant
- How many people
- 75 participants
- Where
- 1 siteNetherlands
- Study dates
- 16 Apr 2024to 1 Oct 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: All patients were included in a prospective randomized clinical trial comparing alveolar ridge preservation with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing (MEC-2015-016;NL49965.078.14).
Who may be able to join
- All patients previously included in the above mentioned RCT.
Who cannot join
- Patients treated with radiotherapy during follow-up in the head-and-neck region or current chemotherapy; disability (mental and/or physical) to maintain basic oral hygiene procedures.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Mc
Rotterdam, 3015gd
justin pijpe, md dds phd, +31641397764, j.pijpe@erasmusmc.nl
About this study
Official title: Alveolar Ridge Preservation With a Xenograft (Bio-Oss® Collagen) and a Collagen Matrix (Mucograft® Seal) or a Free Connective Tissue Graft Versus Spontaneous Healing:A 5-year Follow up
Rationale: Early implant placement with alveolar ridge preservation (ARP) using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP, up to 1 year after functional loading.
Objective: The aim of this study is to evaluate esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing 5 years after loading
Read more
Study design: prospective observational study with 5-year follow-up
Intervention (if applicable): not applicable
Main study parameters/endpoints: Comparison of the level of the buccal marginal gingiva (midfacial mucosa level) between ARP versus spontaneous healing
Secondary parameters/endpoint: Peri-implant esthetic score (PES) and white esthetic score (WES), complications, implant survival; and success, Plaque Index, Modified bleeding index, Gingival Index, Probing Depth, PROMs, bone and soft tissue volumetric dimensional changes.
Read the detailed description
Replacement of a single tooth in the esthetic zone is a demanding procedure. For optimal esthetic results, no deficiency in both bone and soft tissue is acceptable. Immediately after tooth extraction, the alveolar ridge undergoes horizontal and vertical bone loss. This negatively influences the soft tissue contours, and thus esthetic outcome. Although immediate placement of an implant after extraction leads to acceptable esthetic results, there is an increased risk of mucosal recession due to the lack of adequate soft tissue. Early implant placement, 4 to 8 weeks after extraction, may offer advantages in terms of soft and hard tissue preservation. The main goals when treating the extraction socket in the esthetic zone is to preserve as much as possible existing soft and hard tissue volume as possible for future implant placement. Landsberg described a modified ridge preservation technique called "socket seal surgery" where flap elevation is avoided and it combines both bone and soft tissue grafting prior to implant placement. Closing the extraction site from the oral cavity using a thick epithelized palatal graft enables optimal ridge preservation immediately after tooth extraction. Jung showed that the application of a slowly resorbing biomaterial (BioOss Collagen®, Geistlich) into an extraction socket, covered with an autogenous palatal soft tissue punch graft resulted in a high predictability and reliability for a good esthetic result for future (early) implant placement. Although a soft tissue graft is a relatively easy procedure, patient morbidity is often associated with the second surgical site. An artificial socket seal might prevent donor morbidity associated with soft tissue grafts. A critical determinant for stable esthetic long-term outcomes is integrity and stability of the facial bone wall. The application of a biomaterial into an extraction socket, covered with a collagen matrix or a soft tissue graft, resulted in less vertical and horizontal changes of the alveolar ridge 6 months after extraction. Although there seems to be no difference in the long term change of the buccal soft tissue contour and alveolar ridge between a collagen matrix and an autogenous soft tissue punch graft, there is a lack in data concerning the difference in esthetic outcome between these two methods in early implant placement. Therefore, we evaluated esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with alveolar ridge preservation(ARP) with a xenograft (Bio-Oss® Collagen) and a collagen matrix (Mucograft® Seal) or a free connective tissue graft versus spontaneous healing up to 1 year after functional loading (MEC-2015-016;NL49965.078.14). This study showed that ARP using a xenogeneic bone substitute covered with a collagen matrix or a palatal graft, resulted in less bone resorption and fewer bone augmentation procedures at early implant placement compared to spontaneous healing. One year after functional loading, there was no difference in clinical and esthetical outcomes and similar PROMS between the three treatment modalities. In order to achieve optimal esthetic results, both the bone and soft tissue have to be preserved as good as possible. Not much is known about the long term stability of ARP compared to spontaneous healing and PROMs.
- Conditions
- Dental Implant
What is being measured
The primary outcome is the main question the study is designed to answer.
buccal marginal gingival level
- Is the buccal marginal gingival level (midfacial mucosa level) of implants treated post-extraction with a bone substitute material (BioOss® Collagen) and a collagen matrix (Geistlich Mucograft® Seal) (Group A) or covered with a palatal graft (Group B) more favorable then the buccal marginal gingiva in spontaneous healing (Group C) up to 5 year after functional loading?
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start16 Apr 2024
- Primary completion14 Aug 2025 (estimated)
- Study completion1 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Straumann AG
- Responsible party
- Principal investigator, Dr. Justin Pijpe, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663385
- Sponsor's protocol ID
- NL82943.078.22
- Status last verified
- Aug 2025
- First submitted
- 15 Dec 2022
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alveolar Ridge Preservation With a Xenograft (Bio-Oss® Collagen) and a Collagen Matrix (Mucograft® Seal) or a Free Connective Tissue Graft Versus Spontaneous Healing:A 5-year Follow up
- ClinicalTrials.gov ID
- NCT05663385
- Acronym / sponsor ID
- NL82943.078.22
- Conditions
- Dental Implant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Institut Straumann AG
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 14 Aug 2025 (estimated)
- Study completion
- 1 Oct 2025 (estimated)
- First posted
- 23 Dec 2022 (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.
Rationale: Early implant placement with alveolar ridge preservation (ARP) using either a collagen matrix or a palatal graft rendered similar esthetic, clinical and PROMs to early implant placement without ARP, up to 1 year after functional loading.
Objective: The aim of this study is to evaluate esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing 5 years after loading
Study design: prospective observational study with 5-year follow-up
Intervention (if applicable): not applicable
Main study parameters/endpoints: Comparison of the level of the buccal marginal gingiva (midfacial mucosa level) between ARP versus spontaneous healing
Secondary parameters/endpoint: Peri-implant esthetic score (PES) and white esthetic score (WES), complications, implant survival; and success, Plaque Index, Modified bleeding index, Gingival Index, Probing Depth, PROMs, bone and soft tissue volumetric dimensional changes.
Detailed description
Replacement of a single tooth in the esthetic zone is a demanding procedure. For optimal esthetic results, no deficiency in both bone and soft tissue is acceptable. Immediately after tooth extraction, the alveolar ridge undergoes horizontal and vertical bone loss. This negatively influences the soft tissue contours, and thus esthetic outcome. Although immediate placement of an implant after extraction leads to acceptable esthetic results, there is an increased risk of mucosal recession due to the lack of adequate soft tissue. Early implant placement, 4 to 8 weeks after extraction, may offer advantages in terms of soft and hard tissue preservation. The main goals when treating the extraction socket in the esthetic zone is to preserve as much as possible existing soft and hard tissue volume as possible for future implant placement. Landsberg described a modified ridge preservation technique called "socket seal surgery" where flap elevation is avoided and it combines both bone and soft tissue grafting prior to implant placement. Closing the extraction site from the oral cavity using a thick epithelized palatal graft enables optimal ridge preservation immediately after tooth extraction. Jung showed that the application of a slowly resorbing biomaterial (BioOss Collagen®, Geistlich) into an extraction socket, covered with an autogenous palatal soft tissue punch graft resulted in a high predictability and reliability for a good esthetic result for future (early) implant placement. Although a soft tissue graft is a relatively easy procedure, patient morbidity is often associated with the second surgical site. An artificial socket seal might prevent donor morbidity associated with soft tissue grafts. A critical determinant for stable esthetic long-term outcomes is integrity and stability of the facial bone wall. The application of a biomaterial into an extraction socket, covered with a collagen matrix or a soft tissue graft, resulted in less vertical and horizontal changes of the alveolar ridge 6 months after extraction. Although there seems to be no difference in the long term change of the buccal soft tissue contour and alveolar ridge between a collagen matrix and an autogenous soft tissue punch graft, there is a lack in data concerning the difference in esthetic outcome between these two methods in early implant placement. Therefore, we evaluated esthetic and clinical outcomes and patient satisfaction following single-tooth replacement in the anterior maxilla in patients treated with alveolar ridge preservation(ARP) with a xenograft (Bio-Oss® Collagen) and a collagen matrix (Mucograft® Seal) or a free connective tissue graft versus spontaneous healing up to 1 year after functional loading (MEC-2015-016;NL49965.078.14). This study showed that ARP using a xenogeneic bone substitute covered with a collagen matrix or a palatal graft, resulted in less bone resorption and fewer bone augmentation procedures at early implant placement compared to spontaneous healing. One year after functional loading, there was no difference in clinical and esthetical outcomes and similar PROMS between the three treatment modalities. In order to achieve optimal esthetic results, both the bone and soft tissue have to be preserved as good as possible. Not much is known about the long term stability of ARP compared to spontaneous healing and PROMs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients were included in a prospective randomized clinical trial comparing alveolar ridge preservation with a xenograft and a collagen matrix or a free connective tissue graft versus spontaneous healing (MEC-2015-016;NL49965.078.14).
Key inclusion criteria (1 listed)
- All patients previously included in the above mentioned RCT.
Key exclusion criteria (1 listed)
- Patients treated with radiotherapy during follow-up in the head-and-neck region or current chemotherapy; disability (mental and/or physical) to maintain basic oral hygiene procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
buccal marginal gingival level
Time frame: 5 year
1. Is the buccal marginal gingival level (midfacial mucosa level) of implants treated post-extraction with a bone substitute material (BioOss® Collagen) and a collagen matrix (Geistlich Mucograft® Seal) (Group A) or covered with a palatal graft (Group B) more favorable then the buccal marginal gingiva in spontaneous healing (Group C) up to 5 year after functional loading?
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 12 Aug 2025.
- Individual participant dataSharing planned: No
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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?
An observational study of Dental Implant, run by Erasmus Medical Center at 1 site in Netherlands.
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 1 inclusion and 1 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 12 Aug 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 Netherlands. 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 Justin Pijpe, MD DDS PhD MSc (+31641397764, j.pijpe@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
buccal marginal gingival level (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.