Ridge PreservationNCT03497403
Socket Preservation Procedure Studying Soft and Hard Tissue Outcomes
A study testing Socket preservation experimental in people with Ridge Preservation and Bone Regeneration, run by Harvard School of Dental Medicine at 1 site in United States.
Trial summary
Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Ridge Preservation, Bone Regeneration
- What is being tested?
- Socket preservation experimental
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2016to 29 Sep 2017
- 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 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 20-80 years of age
- healthy with no conditions that could alter wound healing
- requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
- a tooth requiring extraction that is treatment planned for implant placement
- willing to participate in the study and sign the informed consent
- willing to receive clinical exams, radiographs, surgery, two and six week post-operative exams and six month re-entry exam.
Who cannot join
- systemic conditions which could alter wound healing
- tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
- severe local infection at extraction site
- a tooth exhibiting severe resorption of buccal or lingual plates
- absence of keratinized tissue buccal to the tooth to be extracted
- severely reduced vestibular depth (≤ 3.0 mm) at the tooth to be extracted.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
About this study
Official title: Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols
Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.
Read the detailed description
The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline \& 6-months.
- Conditions
- Ridge Preservation, Bone Regeneration
- Being tested
- Socket preservation control, Socket preservation experimental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservation controlProcedure or surgery
After a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.
Socket preservation experimentalProcedure or surgery
After a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Socket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing. Receives: Procedure: Socket preservation control |
| Experimental | Experimental | Socket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing. Receives: Procedure: Socket preservation experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Keratinized tissue width
Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.
Measured: 6 months
Secondary outcomes (9)
Keratinized tissue thickness
Keratinized gingival tissue thickness measured with a needle and stopper 3mm from the free gingival margin.
Measured: 6 months
Vestibular Depth
The distance from the free gingival margin to the apical extent of the vestibule measured with a probe.
Measured: 6 months
CEJ-FGM
The distance from the tooth's cervical enamel junction (CEJ) to the free gingival margin (FGM) was taken with a probe.
Measured: 6 months
Ridge Width
After the gum tissue is reflected, the width of the ridge 6mm from the crest was measured with a caliper.
Measured: 6 months
CEJ- Buccal crest
The distance from the tooth's cervical enamel junction and the top of the buccal bone crest was taken with a probe.
Measured: 6 months
CBCT bone height
CBCT scans were taken and the alveolar ridge height was then measured.
Measured: 6 months
CBCT bone width
CBCT scans were taken and the alveolar ridge width was then measured.
Measured: 6 months
Cast ridge width
Dental impressions were taken and stone casts obtained from them.The ridge width was then measured with calipers.
Measured: 6 months
Cast ridge volume
Dental impressions were taken and stone casts obtained from them.The ridge volume was measured using an optical scanner.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2018
- Study start18 Oct 2016
- Primary completion19 Apr 2017
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ridge PreservationStudies 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
- Model description
- Participants were assigned to one of two groups in parallel for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard School of Dental Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Valeant Pharmaceuticals
- Responsible party
- Principal investigator, Heather Hong, Harvard School of Dental Medicine
- Investigators
- Eli Machtei, DMD, Principal investigator, Harvard School of Dental Med.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03497403
- Sponsor's protocol ID
- IRB15-3772
- Status last verified
- Apr 2018
- First submitted
- 5 Apr 2018
- Last updated
- 13 Apr 2018
- 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 13 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Socket Preservation Revisited: RCT to Study the Three-dimensional Changes of Hard and Soft Tissue Comparing Two Distinct Surgical Protocols
- ClinicalTrials.gov ID
- NCT03497403
- Acronym / sponsor ID
- IRB15-3772
- Conditions
- Ridge Preservation, Bone Regeneration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Harvard School of Dental MedicineUniversity, hospital or other
- Collaborators
- Valeant Pharmaceuticals
- Study start
- 18 Oct 2016 (actual)
- Primary completion
- 19 Apr 2017 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 13 Apr 2018 (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.
Two different surgical protocols for socket preservation were compared. Soft and hard tissue outcomes were measured clinically and radiographically at baseline and six months post operatively.
Detailed description
The effect of different surgical techniques for socket preservation on soft tissue parameters has seldom been investigated. The aim of this study was to evaluate One with a cross-linked membrane used in secondary intention healing and the other with a non-cross-linked membrane used in primary intentional healing. Thirty subjects requiring tooth extraction were randomly allocated to either control group C (allograft covered with a non-cross-linked collagen membrane with primary closure) or experimental group E (allograft covered with cross-linked collagen membrane left exposed). Sites were surgically re-entered at 6-months. Soft and hard tissue measurements, cone beam computed tomography (CBCT) and cast measurements were taken at baseline \& 6-months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to one of two groups in parallel for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Procedure: Socket preservation controlSocket preservation control. After tooth extraction, bone graft is applied to socket and a non-cross-linked membrane is used in primary intentional healing. |
| Experimental | Experimental | Procedure: Socket preservation experimentalSocket preservation experimental. After tooth extraction, bone graft is applied to socket and a cross-linked membrane is used in secondary intention healing. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between 20-80 years of age
- healthy with no conditions that could alter wound healing
- requiring the extraction of a non-molar tooth with two neighboring teeth on either side and intact bony walls
- a tooth requiring extraction that is treatment planned for implant placement
- willing to participate in the study and sign the informed consent
Key exclusion criteria (6 listed)
- systemic conditions which could alter wound healing
- tooth anatomy requiring aggressive bone removal or greater flap reflection for extraction
- severe local infection at extraction site
- a tooth exhibiting severe resorption of buccal or lingual plates
- absence of keratinized tissue buccal to the tooth to be extracted
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 |
|---|---|---|
| Socket preservation controlAfter a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively. | Procedure or surgery | Control |
| Socket preservation experimentalAfter a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively. | Procedure or surgery | Experimental |
Primary outcome
Keratinized tissue width
Time frame: 6 months
Keratinized gingival tissue width measured from the free gingival margin to the muco-gingival junction.
9 secondary outcomes
Keratinized tissue thickness
Time frame: 6 months
Vestibular Depth
Time frame: 6 months
CEJ-FGM
Time frame: 6 months
Ridge Width
Time frame: 6 months
CEJ- Buccal crest
Time frame: 6 months
CBCT bone height
Time frame: 6 months
CBCT bone width
Time frame: 6 months
Cast ridge width
Time frame: 6 months
Cast ridge volume
Time frame: 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 13 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Ridge Preservation
Recruiting
Effect of Collagen Membrane on Ridge Preservation
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Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
RecruitingPhase 4
Biotivity A-C Membrane Socket Preservation Study
Alveolar Ridge Preservation
Active, not recruiting
Vallomix Socket Preservation Study
Alveolar Ridge Augmentation
Recruiting
Different Approaches for Alveolar Ridge Preservation
Alveolar Ridge Resorption
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.
Eli Machtei, DMD principal investigator
Harvard School of Dental Med.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation experimental in people with Ridge Preservation and Bone Regeneration, run by Harvard School of Dental Medicine 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 6 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 13 Apr 2018. 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?
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?
Keratinized tissue width (time frame: 6 months). 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 13 Apr 2018.