Guided Bone RegenerationNCT06999915
The Effect of IPD on Lateral Bone Augmentation
A study testing Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD in people with Guided Bone Regeneration and Bone Resorption, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Guided Bone Regeneration, Bone Resorption, Diagnostic Imaging
- What is being tested?
- Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Jun 2026to 1 Feb 2028
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years old) patients
- Good medical and psychological health
- Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment
- Need of a tooth/teeth replacement in the incisor, canine or premolar maxillary region that could be provided with an implant-supported fixed prosthesis
- A relatively symmetrical maxillary arch
- A nearly intact contra-lateral alveolar ridge
Show all 12Show fewer
- At least one neighbouring natural tooth present with healthy periodontal conditions
- After implant placement, presence of a buccal bone dehiscence/ fenestration or buccal bone plate thickness of ≤ 1.5 mm requiring GBR (Monje et al., 2022; Jensen et al.,2023, Group 1 ITI Consensus Report).
- At least 4 weeks of post-extraction socket healing and no ridge preservation prior to implant placement.
- No acute infection at the site; adequate availability of bone apical and palatal to obtain implant primary stability
- A functional occlusion with a minimum of 4 occlusal units (i.e., pairs of occluding posterior teeth)
- Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered.
Who cannot join
- Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II).
- Self-reported HIV or other severe immunosuppression.
- Self-reported alcoholism or chronic drug abuse.
- Heavy smokers ( > 10 cigarettes/day)
- Patients reporting use of vape/e-cigarettes
- Self-reported pregnancy or lactation
Show all 14Show fewer
- Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.
- Chronic treatment with anticoagulants (including Aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation/count.
- Untreated caries lesions in neighbouring teeth and untreated/uncontrolled periodontal disease; If patients require periodontal treatment (non-surgical and/or surgical), this will be arranged outside the study protocol and completed prior to enrolment;
- Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement.
- Patients requiring maxillary sinus lift surgery before implant placement or presenting bone dimensions (at any time point of the study) that do not allow implant placement or there is no clinical indication to perform study procedures (i.e. bone augmentation, implant placement).
- Patients not willing to receive animal-derived biomaterials for GBR.
- Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed.
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nikos Donos, DDS, MS, FHEA, FDSRCSEngl., Ph contact
United Kingdom1 site, 1 recruiting
- Recruiting
Barts Health NHS Trust Dental Hospital
London, E1 1BB
Miljana Bacevic, DDS, PhD, +44(0)2078823063, BHNT.Clinicaloralresearchcentre@nhs.net
Tanja Zivanovic, DDS, MS, +44(0)2078823063, BHNT.Clinicaloralresearchcentre@nhs.net
About this study
Official title: Influence of Individual Phenotypical Dimension (IPD) on Hard Tissue Stability Following Lateral Bone Augmentation: a Two-centre Clinical Study
Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction.
There will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.
Read the detailed description
This is a two-centre, prospective, non-inferiority clinical trial with two parallel study groups aimed at radiographically comparing the differences in hard tissue (lateral augmentation) stability following different GBR treatment protocols (contour augmentation or over-contour augmentation). The study consists of 12 visits over a period of approximately 16 to 18 months.
The study will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust, United Kingdom (leading centre) and at Implant Research Centre \& Department of Periodontology, School of Dental Medicine, University of Belgrade, Serbia, according to local guidelines and procedures/interventions detailed below.
- Being tested
- Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD, Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD
- Medical subject headings
- Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPDProcedure or surgery
In this group, a bone level implant (Straumann BLC, SLActive®, Roxolid, Straumann AG, Switzerland) will be placed in an ideal 3D prosthetically guided position to allow for a screw-retained restoration, following the manufacturer's protocol. Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the original bone contour as defined by IPD. A bovine bone mineral graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen). In the test group, bone augmentation will be performed by adding biomaterial 3 mm beyond the Individual Phenotypical Dimension (IPD) to achieve over-contour augmentation. IPD will be clinically defined during surgery by connecting the most labially prominent points of adjacent ridges at the level of the bone zenith of neighboring teeth.
Group 2 (Control Group): IP and GBR as a contour augmentation up to IPDProcedure or surgery
In this group, a bone level implant (Straumann BLC, SLActive®, Roxolid, Straumann AG, Switzerland) will be placed in an ideal 3D prosthetically guided position to allow for a screw-retained restoration, following the manufacturer's protocol. Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the original bone contour as defined by IPD. A bovine bone mineral graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen). In the control group, bone augmentation will be performed by adding biomaterial up to the IPD line in order to achieve a contour augmentation with bone grafting remaining within the boundaries defined by the IPD. IPD will be clinically defined during surgery by connecting the most labially prominent points of adjacent ridges at the level of the bone zenith of neighboring teeth
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD | Experimental | Implant placement and simultaneous guided bone regeneration (GBR) beyond Individual Phenotypical Dimension (IPD). In this group, lateral bone augmentation will be performed as an over-contour augmentation of 3 mm beyond IPD. Receives: Procedure: Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD |
| Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD | Active comparator | Implant placement and simultaneous guided bone regeneration (GBR) up to IPD. In this group, lateral bone augmentation will be performed up to IPD Receives: Procedure: Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Linear dimensional (LD) changes of the buccal aspect of the augmented alveolar ridge
The primary objective is to compare radiographically the differences in the hard tissue stability (linear dimensional changes of the augmented ridge) following guided bone regeneration (GBR) simultaneous to implant placement (IP), when lateral bone augmentation is performed up to Individual Phenotypical Dimension (IPD) (control group) or as an over-contour augmentation beyond IPD (test group).
Measured: baseline, immediately after implant placement (IP) and 12 months after implant loading (IL)
Secondary outcomes (17)
Cross-sectional area changes of the buccal aspect of the augmented ridge
Cross-sectional area changes of the buccal aspect of the augmented ridge across the whole length of the implant (mm) (ROI) from the time of implant placement (IP) to 12 months after implant loading (IL), assessed by superimposing and comparing CBCT data from different visits.
Measured: baseline, immediately after IP and 12 months after IL
Blood flow changes
Blood flow changes at baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP
Measured: baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP
Soft tissue volume changes
Soft tissue volume changes at baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP, immediately after IL, 6 and 12 months after IL
Measured: baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP, immediately after IL, 6 and 12 months after IL
Extra-oral 3D geometric changes
Extra-oral 3D geometric changes assessed with a facial chairside scanner at baseline, immediately after, 1, 3, 7, 15 and 30 days after IP
Measured: baseline, immediately after, 1, 3, 7, 15 and 30 days after IP
Full mouth plaque score (FMPS)
FMPS will be recorded as a percentage of total surfaces (6 sites per tooth/implant), which reveal the presence of plaque. A binary score will be assigned to each surface (1 for plaque present, 0 for absent).
Measured: baseline, 6 and 12 months after IL
Full mouth bleeding score (FMBS)
FMBS will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of bleeding within 10 - 30 seconds following periodontal probing. A binary score will be assigned to each surface (1 for bleeding present, 0 for bleeding absent).
Measured: baseline, 6 and 12 months after IL
Probing pocket depth (PPD)
PPD will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/ implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual)
Measured: baseline, 6 and 12 months after IL
Gingival recession (REC)
REC will be measured in mm using a University of North Carolina (UNC-15) periodontal probe at six sites per tooth/ implant (i.e., mesiobuccal, buccal, distobuccal, mesiolingual, lingual, and distolingual)
Measured: baseline, 6 and 12 months after IL
Clinical attachment level (CAL)
CAL will be calculated considering the values for PPD and REC in mm
Measured: baseline, 6 and 12 months after IL
Suppuration
Suppuration will be recorded as percentage of total surfaces (6 aspects per tooth/implant), which reveal the presence of suppuration following periodontal probing. A binary score will be assigned to each surface (1 for suppuration present, 0 for suppuration absent)
Measured: baseline, 6 and 12 months after IL
Implant success/survival
Implant success will be based on well-defined criteria by Albrektsson et al. (1986) and survival defined as any dental implant which remained in situ (ITI consensus 2004) 6 and 12 months after IL. Modified success criteria will be applied to incorporate the aesthetic outcomes in success rates
Measured: 6 and 12 months after IL
Changes in the pink esthetic score (PES)
Changes in the pink esthetic score (PES) from loading to 6 and 12 months after loading.
PES is a cumulative score, where seven variables are evaluated using a 0-1-2 scoring system, with the scores 14 and 0 being the best and the worst outcomes, respectively
Measured: immediately after IL, 6 and 12 months after IL
Changes in the white esthetic score (WES)
Changes in the white esthetic score (WES) from loading to 6 and 12 months after loading.
The WES is a cumulative score where five subgroups are assessed using a 0-1-2 scoring system, with the scores 10 and 0 being the best and the worst outcomes, respectively
Measured: immediately after IL, 6 and 12 months after IL
Early healing index
Visual assessment of gingival healing and recording of wound healing (Wachtel et al., 2003) will be assessed during follow-ups at 1, 3, 7 and 15 days after the surgical intervention.
Measured: 1, 3, 7, 15 days after IP
Patient satisfaction
Each patient will be asked to rate their functional and aesthetic satisfaction regarding the overall implant treatment using a subjective outcome questionnaire immediately after IL, 6 and 12 after IL. The questionnaire includes seven questions to be answered in a 5-level Likert scale (poor; fair; good; very good; excellent) (Fava, Lin, Zahran, \& Jokstad, 2015).
Measured: immediately after IL, 6 and 12 after IL
Life impact questionnaire
Numerical rating scale (NRS) ranging from 0-10 will be complemented with a questionnaire to assess post-surgical pain and swelling at 1, 3, 7 and 15 days.
Measured: 1, 3, 7 and 15 days after IP
Patients' aesthetic satisfaction
A visual analogue scale (VAS) rating the overall patients' aesthetic perception of final restoration will also be recorded on the day of the implant loading with monolithic zirconia screw-retained crowns to 6 and 12 months after IL (Aitken, 1969). The scale will range from 0 (very poor aesthetics) to 10 (excellent aesthetics) and the subject can indicate the degree of satisfaction by marking vertically across the VAS scale.
Measured: immediately after IL, 6 and 12 months after IL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start24 Jun 2026
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided Bone RegenerationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Belgrade
- Responsible party
- Sponsor
- Investigators
- Nikos Mardas, DDS, MS, PhD, Principal investigator, QMUL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06999915
- Sponsor's protocol ID
- IRAS Project ID: 358068
- Status last verified
- Sep 2026
- First submitted
- 9 May 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Individual Phenotypical Dimension (IPD) on Hard Tissue Stability Following Lateral Bone Augmentation: a Two-centre Clinical Study
- ClinicalTrials.gov ID
- NCT06999915
- Acronym / sponsor ID
- IRAS Project ID: 358068
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- University of Belgrade
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 31 May 2025 (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.
Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction.
There will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.
Detailed description
This is a two-centre, prospective, non-inferiority clinical trial with two parallel study groups aimed at radiographically comparing the differences in hard tissue (lateral augmentation) stability following different GBR treatment protocols (contour augmentation or over-contour augmentation). The study consists of 12 visits over a period of approximately 16 to 18 months.
The study will take place at the Centre for Oral Clinical Research (COCR), at the Institute of Dentistry, Faculty of Medicine and Dentistry, Queen Mary University of London under The Royal London Dental Hospital, Barts Health NHS Trust, United Kingdom (leading centre) and at Implant Research Centre \& Department of Periodontology, School of Dental Medicine, University of Belgrade, Serbia, according to local guidelines and procedures/interventions detailed below.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD | Experimental | Procedure: Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPDImplant placement and simultaneous guided bone regeneration (GBR) beyond Individual Phenotypical Dimension (IPD). In this group, lateral bone augmentation will be performed as an over-contour augmentation of 3 mm beyond IPD. |
| Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD | Active comparator | Procedure: Group 2 (Control Group): IP and GBR as a contour augmentation up to IPDImplant placement and simultaneous guided bone regeneration (GBR) up to IPD. In this group, lateral bone augmentation will be performed up to IPD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult (>18 years old) patients
- Good medical and psychological health
- Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment
- Need of a tooth/teeth replacement in the incisor, canine or premolar maxillary region that could be provided with an implant-supported fixed prosthesis
- A relatively symmetrical maxillary arch
Key exclusion criteria (14 listed)
- Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II).
- Self-reported HIV or other severe immunosuppression.
- Self-reported alcoholism or chronic drug abuse.
- Heavy smokers ( > 10 cigarettes/day)
- Patients reporting use of vape/e-cigarettes
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 |
|---|---|---|
| Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPDIn this group, a bone level implant (Straumann BLC, SLActive®, Roxolid, Straumann AG, Switzerland) will be placed in an ideal 3D prosthetically guided position to allow for a screw-retained restoration, following the manufacturer's protocol. Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the original bone contour as defined by IPD. A bovine bone mineral graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen). In the test group, bone augmentation will be performed by adding biomaterial 3 mm beyond the Individual Phenotypical Dimension (IPD) to achieve over-contour augmentation. IPD will be clinically defined during surgery by connecting the most labially prominent points of adjacent ridges at the level of the bone zenith of neighboring teeth. | Procedure or surgery | Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD |
| Group 2 (Control Group): IP and GBR as a contour augmentation up to IPDIn this group, a bone level implant (Straumann BLC, SLActive®, Roxolid, Straumann AG, Switzerland) will be placed in an ideal 3D prosthetically guided position to allow for a screw-retained restoration, following the manufacturer's protocol. Guided bone regeneration (GBR) will be performed simultaneously with the implant placement with the aim to re-establish the original bone contour as defined by IPD. A bovine bone mineral graft (Bio-Oss collagen®, Geistlich, Wolhusen, Switzerland) will be placed on the buccal aspect of the implant and covered with a collagen membrane (Bio-Gide®, Geistlich, Wolhusen). In the control group, bone augmentation will be performed by adding biomaterial up to the IPD line in order to achieve a contour augmentation with bone grafting remaining within the boundaries defined by the IPD. IPD will be clinically defined during surgery by connecting the most labially prominent points of adjacent ridges at the level of the bone zenith of neighboring teeth | Procedure or surgery | Group 2 (Control Group): IP and GBR as a contour augmentation up to IPD |
Primary outcome
Linear dimensional (LD) changes of the buccal aspect of the augmented alveolar ridge
Time frame: baseline, immediately after implant placement (IP) and 12 months after implant loading (IL)
The primary objective is to compare radiographically the differences in the hard tissue stability (linear dimensional changes of the augmented ridge) following guided bone regeneration (GBR) simultaneous to implant placement (IP), when lateral bone augmentation is performed up to Individual Phenotypical Dimension (IPD) (control group) or as an over-contour augmentation beyond IPD (test group).
17 secondary outcomes
Cross-sectional area changes of the buccal aspect of the augmented ridge
Time frame: baseline, immediately after IP and 12 months after IL
Blood flow changes
Time frame: baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP
Soft tissue volume changes
Time frame: baseline, immediately after, and at 1, 3, 7, 15, 30 days after IP, immediately after IL, 6 and 12 months after IL
Extra-oral 3D geometric changes
Time frame: baseline, immediately after, 1, 3, 7, 15 and 30 days after IP
Full mouth plaque score (FMPS)
Time frame: baseline, 6 and 12 months after IL
Full mouth bleeding score (FMBS)
Time frame: baseline, 6 and 12 months after IL
Probing pocket depth (PPD)
Time frame: baseline, 6 and 12 months after IL
Gingival recession (REC)
Time frame: baseline, 6 and 12 months after IL
Clinical attachment level (CAL)
Time frame: baseline, 6 and 12 months after IL
Suppuration
Time frame: baseline, 6 and 12 months after IL
Implant success/survival
Time frame: 6 and 12 months after IL
Changes in the pink esthetic score (PES)
Time frame: immediately after IL, 6 and 12 months after IL
Changes in the white esthetic score (WES)
Time frame: immediately after IL, 6 and 12 months after IL
Early healing index
Time frame: 1, 3, 7, 15 days after IP
Patient satisfaction
Time frame: immediately after IL, 6 and 12 after IL
Life impact questionnaire
Time frame: 1, 3, 7 and 15 days after IP
Patients' aesthetic satisfaction
Time frame: immediately after IL, 6 and 12 months after IL
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 23 Sep 2026.
Related trials for Guided Bone Regeneration
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
Recruiting
Guided Bone Regeneration Using Polydioxanone (PDO) Membrane in Sockets After Tooth Extraction
Surgery, Oral
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
Not yet recruiting
Comparison of Three Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
Not yet recruiting
Comparison of Two Autogenous Bone and Xenograft Ratios for Horizontal Ridge Augmentation
Horizontal Alveolar Ridge Deficiency
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.
Nikos Donos, DDS, MS, FHEA, FDSRCSEngl., Ph contact
Nikos Mardas, DDS, MS, PhD principal investigator
QMUL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1 (Test Group): IP and GBR as an over-contour augmentation beyond IPD in people with Guided Bone Regeneration and Bone Resorption, run by Queen Mary University of London at 1 site in United Kingdom.
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 12 inclusion and 14 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 23 Sep 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 United Kingdom. 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 Miljana Bacevic, DDS, PhD (02078828641, BHNT.Clinicaloralresearchcentre@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Linear dimensional (LD) changes of the buccal aspect of the augmented alveolar ridge (time frame: baseline, immediately after implant placement (IP) and 12 months after implant loading (IL)). 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 23 Sep 2026.