Alveolar Ridge PreservationNCT05517798
Enamel Matrix Derivative for Alveolar Ridge Preservation After Tooth Extraction
A study testing Alveolar ridge preservation in people with Alveolar Ridge Preservation, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
Trial summary
The Global Burden of Disease Study of 2016 considered oral disease as the most common noncommunicable disease that affected half of the world population throughout their lifetime. Dental caries and periodontal diseases may cause pain and discomfort with severe forms of periodontal diseases causing tooth loss. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alveolar Ridge Preservation
- What is being tested?
- Alveolar ridge preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Sep 2021to 1 Sep 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or over.
- Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
- The tooth that requires extraction is bordered by two teeth.
- Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
- Good compliance and commitment to attend follow-up review appointments.
- Willing to provide informed consent.
Who cannot join
- Localised / generalised periodontitis.
- Presence of acute periapical lesion.
- Bone metabolic disease and/or taking medications that affect bone metabolism.
- Long term use of non-steroidal anti-inflammatory medications.
- History of malignancy, radiotherapy or chemotherapy.
- Pregnant or lactating women.
- Severe bruxism or parafunctional habits.
- Large occlusal discrepancies.
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Dubai Dental Hospital
Dubai, 505097
Momen A Atieh, BDS, MSc, DClinDent, PhD, +971 4 383 8905, momen.atieh@mbru.ac.ae
About this study
Official title: Enamel Matrix Derivative for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial
The Global Burden of Disease Study of 2016 considered oral disease as the most common noncommunicable disease that affected half of the world population throughout their lifetime. Dental caries and periodontal diseases may cause pain and discomfort with severe forms of periodontal diseases causing tooth loss. Periodontal disease and tooth loss were estimated to be one of the ten causes of Years Lived with Disability. The dimensional changes in the alveolar ridge following tooth loss have been extensively investigated in the literature. At six months after tooth loss, a systematic review on bone remodelling showed horizontal and vertical bone loss of 29-63% and 11-22%, respectively. Such bone loss may complicate replacement of missing teeth with dental implants.
Dental implant is now a common treatment modality. However, the loss of bone volume may not allow the placement of dental implant in an optimal position and may subsequently jeopardize functional and aesthetic implant outcomes. Therefore, the use of bone replacement graft following tooth extraction, as part of a procedure termed alveolar ridge preservation (ARP), has increasingly becoming a common treatment protocol to optimize dental implant placement in the future.
Read more
A Cochrane review on ARP has demonstrated that there are no significant differences between the plethora of synthetic or biologically driven grafting materials used to minimize changes in width and height of the extraction sockets. Nevertheless, a regenerative agent, known as enamel matrix derivative (EMD), has gained more attention in regenerative therapy over the last 20 years. Several studies demonstrated its ability to enhance wound healing, induce new attachment and promote bone formation in recession and intrabony defects. Over the last two decades, EMD has been successfully used in the periodontal regeneration of intrabony defects. EMD has the potential to cause early vascularization and support early bone formation, hence, it can be considered as a potential regenerative agent for ARP when used with appropriate carrier material.
Moreover, the majority of studies showed that bone substitutes generally performed well in small or contained defects compared with non-grafted sites, but there is lack of information regarding the efficacy of different bone substitute materials in large defects. Short-term follow-up studies of three to six months have also dominated the literature when the main aim of the ARP is to develop a site that optimise long-term implant outcomes. Such aim requires evaluating the long-term performance of dental implants placed in preserved ridges and reporting patient outcomes in well-conducted randomized controlled trial.
The aim of the present clinical trial is to evaluate the adjunctive use of EMD in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes.
Read the detailed description
A total of 34 participants, attending Dubai Dental Hospital, will be invited to take part in this randomized controlled trial. The participants will be randomly allocated to two equal sized groups (17 per group) using computer-generated numbers:
Control group (C): Xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Wolhusen, Switzerland) + resorbable collagen membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland).
Test group (T): Xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland) combined with EMD (Straumann Emdogain, Straumann AG, Basel, Switzerland) + resorbable collagen membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland). The minimally traumatic extraction of the tooth will include raising a full mucoperiosteal flap and sectioning the roots if required. This will allow visual assessment of the socket walls and thorough debridement of the extraction socket. A clinician not involved in the study will then open a sealed opaque envelope and ARP procedure will be carried out by placing either xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland) alone or combined with EMD (Straumann Emdogain, Straumann AG, Basel, Switzerland). The xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland) will pre-wetted with blood or saliva prior to applying it to the socket. EMD (Straumann Emdogain, Straumann AG, Basel, Switzerland) will then be placed into the socket. Xenograft will not be mized with EMD outside the oral cavity. In both groups, a resorbable collagen membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland) will be trimmed and adapted to cover the socket. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.
After six months of healing, CBCT will be utilized in the assessment of the available bone volume and virtual implant treatment planning. A three-dimensional printed surgical stent will be fabricated to aid in implant placement. The implant site will then be prepared according to the surgical protocol outlined in the International Team for Implantology (ITI) consensus conference. This procedure will include raising a mucoperiosteal flap with slightly palatal crestal incision and sulcular incision extending to the adjacent teeth. The osteotomy will be prepared to place a chemically modified, sand-blasted and acid-etched dental implants. In the presence of peri-implant bone defect, simultaneous contour augmentation will be carried out. For all implant surgeries, two-stage protocol will be followed with a re-opening procedure after 12 weeks to place a healing abutment.
Prosthodontic Protocol The restorative phase will be carried out in a partial or complete digital workflow. Within 21-28 days of placing the healing abutment, the implant position will be captured using an intraoral optical scanner. Computer-aided design / computer-aided manufacturing (CAD/CAM) will be utilizing the captured digital data to design a screw-retained crown, which will then be milled of monolithic lithium disilicate blanks and bonded to pre-fabricated titanium abutments.
- Conditions
- Alveolar Ridge Preservation
- Being tested
- Alveolar ridge preservation
- Keywords
- Alveolar ridge preservation, Dental implants, Enamel matrix derivative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alveolar ridge preservationProcedure or surgery
Alveolar ridge preservation is a method of decreasing bone resorption following tooth extraction and facilitating prosthetically-driven implant placement
| Study group | Role | What they receive |
|---|---|---|
| Xenograft + resorbable collagen membrane | Active comparator | Bone grafting material (bovine origin) + resorbable collagen membrane (porcine origin) Receives: Procedure: Alveolar ridge preservation |
| Xenograft combined with EMD + resorbable collagen membrane | Active comparator | Bone grafting material (bovine origin) with enamel matrix derivative (porcine origin) + resorbable collagen membrane (porcine origin) Receives: Procedure: Alveolar ridge preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival / success rate after one year
'Implant survival' means that implants are still in the mouth at the time of examination
Measured: 1 year
Patient postoperative experience
Postoperative experience means any events occurring after and relating to the procedure
Measured: 1 week
Implant survival / success rate after two years
'Implant survival' means that implants are still in the mouth at the time of examination
Measured: 2 years
Implant survival / success rate after three years
'Implant survival' means that implants are still in the mouth at the time of examination
Measured: 3 years
Secondary outcomes (4)
Changes in width and height of alveolar ridge
Differences in bony dimensions before and after alveolar ridge preservation, meaasured in millimeters using cone beam computed tomography
Measured: 6 months
Bone quality
Bone quality relates to the degree of bone density present
Measured: 1 day
Need for additional bone augmentation
Since all the sites had alveolar ridge preservation, we would like to assess whether another bone grafting is required at the time of placing implants. The assessment is YES or NO and it is only assessed ONE TIME ... AT THE TIME OF IMPLANT PLACEMENT
Measured: 1 day
Changes in peri-implant marginal bone level
Differences in level of bone surrounding the implant
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Sep 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Associate Professor Momen Atieh, Mohammed Bin Rashid University of Medicine and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517798
- Sponsor's protocol ID
- MBRUMHS
- Status last verified
- Aug 2022
- First submitted
- 11 Sep 2021
- Last updated
- 26 Aug 2022
- 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 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enamel Matrix Derivative for Alveolar Ridge Preservation After Tooth Extraction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05517798
- Acronym / sponsor ID
- MBRUMHS
- Conditions
- Alveolar Ridge Preservation
- Keywords
- Alveolar ridge preservation, Dental implants, Enamel matrix derivative
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Mohammed Bin Rashid University of Medicine and Health SciencesUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 26 Aug 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.
The Global Burden of Disease Study of 2016 considered oral disease as the most common noncommunicable disease that affected half of the world population throughout their lifetime. Dental caries and periodontal diseases may cause pain and discomfort with severe forms of periodontal diseases causing tooth loss. Periodontal disease and tooth loss were estimated to be one of the ten causes of Years Lived with Disability. The dimensional changes in the alveolar ridge following tooth loss have been extensively investigated in the literature. At six months after tooth loss, a systematic review on bone remodelling showed horizontal and vertical bone loss of 29-63% and 11-22%, respectively. Such bone loss may complicate replacement of missing teeth with dental implants.
Dental implant is now a common treatment modality. However, the loss of bone volume may not allow the placement of dental implant in an optimal position and may subsequently jeopardize functional and aesthetic implant outcomes. Therefore, the use of bone replacement graft following tooth extraction, as part of a procedure termed alveolar ridge preservation (ARP), has increasingly becoming a common treatment protocol to optimize dental implant placement in the future.
A Cochrane review on ARP has demonstrated that there are no significant differences between the plethora of synthetic or biologically driven grafting materials used to minimize changes in width and height of the extraction sockets. Nevertheless, a regenerative agent, known as enamel matrix derivative (EMD), has gained more attention in regenerative therapy over the last 20 years. Several studies demonstrated its ability to enhance wound healing, induce new attachment and promote bone formation in recession and intrabony defects. Over the last two decades, EMD has been successfully used in the periodontal regeneration of intrabony defects. EMD has the potential to cause early vascularization and support early bone formation, hence, it can be considered as a potential regenerative agent for ARP when used with appropriate carrier material.
Moreover, the majority of studies showed that bone substitutes generally performed well in small or contained defects compared with non-grafted sites, but there is lack of information regarding the efficacy of different bone substitute materials in large defects. Short-term follow-up studies of three to six months have also dominated the literature when the main aim of the ARP is to develop a site that optimise long-term implant outcomes. Such aim requires evaluating the long-term performance of dental implants placed in preserved ridges and reporting patient outcomes in well-conducted randomized controlled trial.
The aim of the present clinical trial is to evaluate the adjunctive use of EMD in promoting the desired vascularization and bone fill in small and large defects following tooth extraction and report on the long-term implant and patient outcomes.
Detailed description
A total of 34 participants, attending Dubai Dental Hospital, will be invited to take part in this randomized controlled trial. The participants will be randomly allocated to two equal sized groups (17 per group) using computer-generated numbers:
Control group (C): Xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Wolhusen, Switzerland) + resorbable collagen membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland).
Test group (T): Xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland) combined with EMD (Straumann Emdogain, Straumann AG, Basel, Switzerland) + resorbable collagen membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland). The minimally traumatic extraction of the tooth will include raising a full mucoperiosteal flap and sectioning the roots if required. This will allow visual assessment of the socket walls and thorough debridement of the extraction socket. A clinician not involved in the study will then open a sealed opaque envelope and ARP procedure will be carried out by placing either xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland) alone or combined with EMD (Straumann Emdogain, Straumann AG, Basel, Switzerland). The xenograft (Bio-Oss Collagen, Geistlich Pharma AG, Switzerland) will pre-wetted with blood or saliva prior to applying it to the socket. EMD (Straumann Emdogain, Straumann AG, Basel, Switzerland) will then be placed into the socket. Xenograft will not be mized with EMD outside the oral cavity. In both groups, a resorbable collagen membrane (Bio-Gide; Geistlich Pharma AG, Wolhusen, Switzerland) will be trimmed and adapted to cover the socket. The flaps will then be replaced and sutured with 4/0 polyglycolic acid interrupted and mattress sutures.
After six months of healing, CBCT will be utilized in the assessment of the available bone volume and virtual implant treatment planning. A three-dimensional printed surgical stent will be fabricated to aid in implant placement. The implant site will then be prepared according to the surgical protocol outlined in the International Team for Implantology (ITI) consensus conference. This procedure will include raising a mucoperiosteal flap with slightly palatal crestal incision and sulcular incision extending to the adjacent teeth. The osteotomy will be prepared to place a chemically modified, sand-blasted and acid-etched dental implants. In the presence of peri-implant bone defect, simultaneous contour augmentation will be carried out. For all implant surgeries, two-stage protocol will be followed with a re-opening procedure after 12 weeks to place a healing abutment.
Prosthodontic Protocol The restorative phase will be carried out in a partial or complete digital workflow. Within 21-28 days of placing the healing abutment, the implant position will be captured using an intraoral optical scanner. Computer-aided design / computer-aided manufacturing (CAD/CAM) will be utilizing the captured digital data to design a screw-retained crown, which will then be milled of monolithic lithium disilicate blanks and bonded to pre-fabricated titanium abutments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xenograft + resorbable collagen membrane | Active comparator | Procedure: Alveolar ridge preservationBone grafting material (bovine origin) + resorbable collagen membrane (porcine origin) |
| Xenograft combined with EMD + resorbable collagen membrane | Active comparator | Procedure: Alveolar ridge preservationBone grafting material (bovine origin) with enamel matrix derivative (porcine origin) + resorbable collagen membrane (porcine origin) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 or over.
- Require extraction of anterior or posterior single tooth due to caries, endodontic and prosthetic complications.
- The tooth that requires extraction is bordered by two teeth.
- Controlled oral hygiene (full-mouth plaque and bleeding scores ≤ 25% at baseline).
- Good compliance and commitment to attend follow-up review appointments.
Key exclusion criteria (8 listed)
- Localised / generalised periodontitis.
- Presence of acute periapical lesion.
- Bone metabolic disease and/or taking medications that affect bone metabolism.
- Long term use of non-steroidal anti-inflammatory medications.
- History of malignancy, radiotherapy or chemotherapy.
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 |
|---|---|---|
| Alveolar ridge preservationAlveolar ridge preservation is a method of decreasing bone resorption following tooth extraction and facilitating prosthetically-driven implant placement | Procedure or surgery | Xenograft + resorbable collagen membrane, Xenograft combined with EMD + resorbable collagen membrane |
Primary outcome
Implant survival / success rate after one year
Time frame: 1 year
'Implant survival' means that implants are still in the mouth at the time of examination
Patient postoperative experience
Time frame: 1 week
Postoperative experience means any events occurring after and relating to the procedure
Implant survival / success rate after two years
Time frame: 2 years
'Implant survival' means that implants are still in the mouth at the time of examination
Implant survival / success rate after three years
Time frame: 3 years
'Implant survival' means that implants are still in the mouth at the time of examination
4 secondary outcomes
Changes in width and height of alveolar ridge
Time frame: 6 months
Bone quality
Time frame: 1 day
Need for additional bone augmentation
Time frame: 1 day
Changes in peri-implant marginal bone level
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alveolar ridge preservation in people with Alveolar Ridge Preservation, run by Mohammed Bin Rashid University of Medicine and Health Sciences at 1 site in United Arab Emirates.
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 8 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: status not confirmed, as of the sponsor's last update on 26 Aug 2022. 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 Arab Emirates. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant survival / success rate after one year (time frame: 1 year). The study lists 4 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 26 Aug 2022.