Alveolar Bone GraftingNCT06624982
Determinants of Bone Dimensional Changes After Extraction and Alveolar Ridge Preservation
An observational study of Alveolar Bone Grafting and Bone Healing, run by Marquette University at 1 site in United States.
Trial summary
The main purpose of the study is to measure and localize immediate post extraction changes i.e. socket expansion versus no width change along the socket wall and identify whether the immediate post-extraction ridge width condition (expansion or no change) is a determinant of buccolingual ridge width and height changes… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Grafting, Bone Healing, Tooth Extraction Site Healing
- What is being tested?
- observational study
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2025to 1 Oct 2027
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients scheduled for tooth extraction and alveolar ridge preservation (bone graft and membrane) in the Graduate Periodontics Clinic at Marquette University School of Dentistry.
Who may be able to join
- Adult patients (18-75 years)
- Good general health (controlled conditions)
- Controlled periodontal disease
- Scheduled for single tooth extraction with bone graft placement and resorbable membrane
- Tooth to be extracted must have adjacent teeth
- Socket wall integrity
Who cannot join
- Smoking
- Pregnancy
- Active periodontal disease
- Systemic conditions that affect healing
- Lack of socket wall integrity (bone loss ≥50 %) prior to extraction, teeth with severe infection requiring pre-extraction antibiotic treatment to control infection), and contraindications for tooth extraction.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Marquette University School of Dentistry Graduate Periodontics Clinic
Milwaukee, Wisconsin, 53233
Vrisiis Kofina, DDS, MS, 4142886521, vrisiis.kofina@marquette.edu
Arndt Guentsch, DMD, PhD, MHBA, MS, 4142886089, arndt.guentsch@marquette.edu
About this study
The main purpose of the study is to measure and localize immediate post extraction changes i.e. socket expansion versus no width change along the socket wall and identify whether the immediate post-extraction ridge width condition (expansion or no change) is a determinant of buccolingual ridge width and height changes 4 months following extraction and ridge preservation.
Read the detailed description
The null hypothesis for this study is that there is no difference in bone ridge width and height changes 4 months following extraction and alveolar ridge preservation at sites that undergo immediate post-extraction socket expansion or no immediate post-extraction ridge width change. Patients of the Graduate Periodontics Clinic at Marquette University School of Dentistry scheduled for extraction, bone graft and resorbable membrane will be recruited for this study.
After providing informed consent and prior to local anesthesia and extraction, the following parameters will be recorded: age, gender, race, medical history, medications, tooth site, reason for extraction and tooth mobility. Gingival width will be recorded prior to local anesthesia and extraction, and at 4 months. Gingival thickness will be recorded after local anesthesia and prior to extraction, and at 4 months. Buccolingual ridge width and ridge height will be recorded immediately before, immediately after extraction, and at 4 months. Immediately after extraction, the following measurements will be recorded: buccal bone thickness, number of roots, root length and width, instruments used for extraction, need for flap elevation, duration of extraction, anesthetic amount, type and approach, and operator experience.
- Being tested
- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Observational study; alveolar ridge preservation
| Study group | Role | What they receive |
|---|---|---|
| Non-molar sites with immediate post-extraction ridge expansion | Non-molar sites with an increase of buccolingual bone width immediately after tooth extraction compared to pre-extraction. Receives: Other: observational study | |
| Non-molar sites with no immediate post-extraction ridge width change | Non-molar sites without a change in buccolingual bone width immediately after tooth extraction compared to pre-extraction. Receives: Other: observational study | |
| Molar sites with immediate post-extraction ridge expansion | Molar sites with an increase of buccolingual bone width immediately after tooth extraction compared to pre-extraction. Receives: Other: observational study | |
| Molar sites with no immediate post-extraction ridge width change | Molar sites without a change in buccolingual bone width immediately after tooth extraction compared to pre-extraction. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccolingual ridge width
Buccolingual ridge width will be measured through a stent via ridge mapping calipers. The measurement locations will be at 1mm, 3mm and 5mm from the midbuccal crest. The same measurements will be recorded at all selected time points.
Measured: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
Ridge height
Ridge height will be measured through a stent via a periodontal probe as the distance between bone and predetermined landmarks on the stent. The measurement locations will be mesial buccal, midbuccal, distal buccal, mesial lingual, midlingual and distal lingual. The same measurements will be recorded at all selected time points.
Measured: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start8 Oct 2025
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone GraftingStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vrisiis Kofina, Marquette University
- Investigators
- Vrisiis Kofina, DDS, MS, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624982
- Sponsor's protocol ID
- HR-4787
- Status last verified
- Nov 2025
- First submitted
- 1 Oct 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Bone Dimensional Changes After Extraction and Alveolar Ridge Preservation
- ClinicalTrials.gov ID
- NCT06624982
- Acronym / sponsor ID
- HR-4787
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- 8 Oct 2025 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 3 Oct 2024 (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 main purpose of the study is to measure and localize immediate post extraction changes i.e. socket expansion versus no width change along the socket wall and identify whether the immediate post-extraction ridge width condition (expansion or no change) is a determinant of buccolingual ridge width and height changes 4 months following extraction and ridge preservation.
Detailed description
The null hypothesis for this study is that there is no difference in bone ridge width and height changes 4 months following extraction and alveolar ridge preservation at sites that undergo immediate post-extraction socket expansion or no immediate post-extraction ridge width change. Patients of the Graduate Periodontics Clinic at Marquette University School of Dentistry scheduled for extraction, bone graft and resorbable membrane will be recruited for this study.
After providing informed consent and prior to local anesthesia and extraction, the following parameters will be recorded: age, gender, race, medical history, medications, tooth site, reason for extraction and tooth mobility. Gingival width will be recorded prior to local anesthesia and extraction, and at 4 months. Gingival thickness will be recorded after local anesthesia and prior to extraction, and at 4 months. Buccolingual ridge width and ridge height will be recorded immediately before, immediately after extraction, and at 4 months. Immediately after extraction, the following measurements will be recorded: buccal bone thickness, number of roots, root length and width, instruments used for extraction, need for flap elevation, duration of extraction, anesthetic amount, type and approach, and operator experience.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-molar sites with immediate post-extraction ridge expansion | – | Other: observational studyNon-molar sites with an increase of buccolingual bone width immediately after tooth extraction compared to pre-extraction. |
| Non-molar sites with no immediate post-extraction ridge width change | – | Other: observational studyNon-molar sites without a change in buccolingual bone width immediately after tooth extraction compared to pre-extraction. |
| Molar sites with immediate post-extraction ridge expansion | – | Other: observational studyMolar sites with an increase of buccolingual bone width immediately after tooth extraction compared to pre-extraction. |
| Molar sites with no immediate post-extraction ridge width change | – | Other: observational studyMolar sites without a change in buccolingual bone width immediately after tooth extraction compared to pre-extraction. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for tooth extraction and alveolar ridge preservation (bone graft and membrane) in the Graduate Periodontics Clinic at Marquette University School of Dentistry.
Key inclusion criteria (6 listed)
- Adult patients (18-75 years)
- Good general health (controlled conditions)
- Controlled periodontal disease
- Scheduled for single tooth extraction with bone graft placement and resorbable membrane
- Tooth to be extracted must have adjacent teeth
Key exclusion criteria (5 listed)
- Smoking
- Pregnancy
- Active periodontal disease
- Systemic conditions that affect healing
- Lack of socket wall integrity (bone loss ≥50 %) prior to extraction, teeth with severe infection requiring pre-extraction antibiotic treatment to control infection), and contraindications for tooth extraction.
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 |
|---|---|---|
| observational studyObservational study; alveolar ridge preservation | Other | Molar sites with immediate post-extraction ridge expansion, Molar sites with no immediate post-extraction ridge width change, Non-molar sites with immediate post-extraction ridge expansion, Non-molar sites with no immediate post-extraction ridge width change |
Primary outcome
Buccolingual ridge width
Time frame: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
Buccolingual ridge width will be measured through a stent via ridge mapping calipers. The measurement locations will be at 1mm, 3mm and 5mm from the midbuccal crest. The same measurements will be recorded at all selected time points.
Ridge height
Time frame: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation
Ridge height will be measured through a stent via a periodontal probe as the distance between bone and predetermined landmarks on the stent. The measurement locations will be mesial buccal, midbuccal, distal buccal, mesial lingual, midlingual and distal lingual. The same measurements will be recorded at all selected time points.
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 17 Nov 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.
Vrisiis Kofina, DDS, MS principal investigator
Marquette University
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 Alveolar Bone Grafting and Bone Healing, run by Marquette University at 1 site in United States.
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 6 inclusion and 5 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 17 Nov 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 United States. 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 Vrisiis Kofina, DDS, MS (4142886521, vrisiis.kofina@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Buccolingual ridge width (time frame: (1) After local anesthesia and before extraction, (2) immediately after extraction and (3) 4 months after extraction and alveolar ridge preservation). The study lists 2 primary outcomes in all. 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 17 Nov 2025.