Bone DefectsNCT07060027
Single vs. Double Tenting Screws for Horizontal Ridge Augmentation.
A study testing horizontal bone augmentation using single tenting screw and horizontal bone augmentation using Double tenting screw in people with Bone Defects, run by Omar Saad at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if using two screws works better than one screw for building up jawbone width before dental implant placement. It will also check the safety of both techniques. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Bone Defects
- What is being tested?
- horizontal bone augmentation using single tenting screw and horizontal bone augmentation using Double tenting screw
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 10 Dec 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients are systemically healthy based on questionnaire dental modification of Cornell index (Bolender, C. L. et al., 1969).
- Gingival health according to the new classification system (Caton, J. G. et al., 2018).
- The recipient site of the augmentation is free from any pathological conditions.
- At least 1 tooth area with a ridge defect and planned to receive a dental implant. The site must be bordered by at least 1 tooth.
- Class I ridge defect according to Seibert's classification.
- Adequate interocclusal space to accommodate the available restorative components.
Who cannot join
- Parafunctional habits such as bruxism and clenching
- Smokers
- Pregnant females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect Of Single Versus Double Screws In Tenting Screw Technique For Horizontal Ridge Augmentation Before Dental Implant Placement (Randomized Clinical Trial)
The goal of this clinical trial is to learn if using two screws works better than one screw for building up jawbone width before dental implant placement. It will also check the safety of both techniques. The main questions it aims to answer are:
- Does using two screws give better bone growth than using one screw?
- Which technique creates more stable bone for dental implants?
Read more
Researchers will compare the single-screw technique to the double-screw technique to see which works better for jawbone reconstruction.
Participants will:
- Receive either one or two small titanium screws placed in their jawbone to support a bone graft
- Have the graft covered with a protective membrane
- Return after 6 months for screw removal and dental implant placement
- Attend follow-up visits to check healing progress
The study will help dentists determine the best method for patients who need jawbone reconstruction before getting dental implants. All procedures use FDA-approved materials and follow standard surgical protocols.
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- Conditions
- Bone Defects
- Being tested
- horizontal bone augmentation using single tenting screw, horizontal bone augmentation using Double tenting screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
horizontal bone augmentation using single tenting screwProcedure or surgery
Patients in this group will undergo guided bone regeneration (GBR) using a single titanium bone screw placed in the crestal position to stabilize the graft material. The surgical procedure includes sulcular and vertical releasing incisions, elevation of full-thickness buccal and palatal/lingual flaps, and multiple cortical perforations to enhance angiogenesis. The defect will be filled with particulate allograft extended 10-12 mm apicocoronally and covered with a bovine pericardium membrane. A tension-free primary closure will be achieved using 5-0 polypropylene sutures. Bone screw removal and implant placement will occur 6 months postoperatively. This group is distinguished by the use of a single crestal screw for graft stabilization compared to dual-screw fixation in the control group.
horizontal bone augmentation using Double tenting screwProcedure or surgery
Participants in this group will receive guided bone regeneration (GBR) with two titanium bone screws for enhanced graft stabilization. One screw will be placed at the crestal level, while a second screw will be inserted 5 mm apical to the first, providing vertical stabilization of the graft material. The procedure involves sulcular and vertical releasing incisions, full-thickness flap elevation on both buccal and palatal/lingual aspects, and multiple cortical perforations to stimulate vascularization. The defect will be filled with particulate allograft extending 10-12 mm apicocoronally and covered with a bovine pericardium membrane. Tension-free primary closure will be performed using 5-0 polypropylene sutures. At 6 months, screws will be removed and dental implants placed. This intervention is distinguished by the dual-screw fixation technique, designed to provide greater mechanical stability compared to the single-screw approach used in the comparator group.
| Study group | Role | What they receive |
|---|---|---|
| Single tenting screw | Experimental | 8 patients indicated for lateral ridge augmentation in premolar-molar area (class I Seibert's classification) will be candidates to screw tent technique using single screw at crest position Receives: Procedure: horizontal bone augmentation using single tenting screw |
| Double tenting screw | Active comparator | 8 patients indicated for lateral ridge augmentation in premolar-molar area (class I Seibert's classification) will be candidates to screw tent technique using double screws, one at a crestal position and the other one 5 mm apical to the first one. Receives: Procedure: horizontal bone augmentation using Double tenting screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Horizontal Ridge Width at Mid-Crestal Level
Ridge width will be measured at the mid-crestal level using a bone caliper to the nearest millimeter. A standardized stent will ensure consistent measurement positioning.
Measured: 6 months post-intervention
Change in Horizontal Ridge Width 5 mm Apical to Crest
Ridge width will be measured 5 mm apical to the crestal level using a bone caliper to the nearest millimeter. The same stent will standardize measurements.
Measured: 6 months post-intervention
Secondary outcomes (3)
Change in Keratinized Mucosa Width at 6 Months Post-Reentry
The width of keratinized mucosa will be measured using a periodontal probe to the nearest millimeter at the reentry procedure, 6 months after the initial intervention. The same stent will be used to standardize measurements.
Measured: 6 months post-intervention
Change in Alveolar Ridge Width via CBCT at 6 Months
Cone-beam computed tomography (CBCT) will be used to assess changes in ridge width at 6 months post-intervention
Measured: 6 months post-intervention
Change in Bone Density via CBCT at 6 Months
CBCT imaging will assess bone density changes (in Hounsfield units or grayscale values) at the treated site after 6 months.
Measured: 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Aug 2022
- Primary completion25 Jan 2024
- Study completion10 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone DefectsStudies 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Omar Saad
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Saad, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07060027
- Sponsor's protocol ID
- 4/626/88/2022
- Status last verified
- Jul 2025
- First submitted
- 10 Jun 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Single Versus Double Screws In Tenting Screw Technique For Horizontal Ridge Augmentation Before Dental Implant Placement (Randomized Clinical Trial)
- ClinicalTrials.gov ID
- NCT07060027
- Acronym / sponsor ID
- 4/626/88/2022
- Conditions
- Bone Defects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Omar SaadUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 10 Dec 2024 (actual)
- First posted
- 11 Jul 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.
The goal of this clinical trial is to learn if using two screws works better than one screw for building up jawbone width before dental implant placement. It will also check the safety of both techniques. The main questions it aims to answer are:
- Does using two screws give better bone growth than using one screw?
- Which technique creates more stable bone for dental implants?
Researchers will compare the single-screw technique to the double-screw technique to see which works better for jawbone reconstruction.
Participants will:
- Receive either one or two small titanium screws placed in their jawbone to support a bone graft
- Have the graft covered with a protective membrane
- Return after 6 months for screw removal and dental implant placement
- Attend follow-up visits to check healing progress
The study will help dentists determine the best method for patients who need jawbone reconstruction before getting dental implants. All procedures use FDA-approved materials and follow standard surgical protocols.
New chat
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single tenting screw | Experimental | Procedure: horizontal bone augmentation using single tenting screw8 patients indicated for lateral ridge augmentation in premolar-molar area (class I Seibert's classification) will be candidates to screw tent technique using single screw at crest position |
| Double tenting screw | Active comparator | Procedure: horizontal bone augmentation using Double tenting screw8 patients indicated for lateral ridge augmentation in premolar-molar area (class I Seibert's classification) will be candidates to screw tent technique using double screws, one at a crestal position and the other one 5 mm apical to the first one. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients are systemically healthy based on questionnaire dental modification of Cornell index (Bolender, C. L. et al., 1969).
- Gingival health according to the new classification system (Caton, J. G. et al., 2018).
- The recipient site of the augmentation is free from any pathological conditions.
- At least 1 tooth area with a ridge defect and planned to receive a dental implant. The site must be bordered by at least 1 tooth.
- Class I ridge defect according to Seibert's classification.
Key exclusion criteria (3 listed)
- Parafunctional habits such as bruxism and clenching
- Smokers
- Pregnant females
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 |
|---|---|---|
| horizontal bone augmentation using single tenting screwPatients in this group will undergo guided bone regeneration (GBR) using a single titanium bone screw placed in the crestal position to stabilize the graft material. The surgical procedure includes sulcular and vertical releasing incisions, elevation of full-thickness buccal and palatal/lingual flaps, and multiple cortical perforations to enhance angiogenesis. The defect will be filled with particulate allograft extended 10-12 mm apicocoronally and covered with a bovine pericardium membrane. A tension-free primary closure will be achieved using 5-0 polypropylene sutures. Bone screw removal and implant placement will occur 6 months postoperatively. This group is distinguished by the use of a single crestal screw for graft stabilization compared to dual-screw fixation in the control group. | Procedure or surgery | Single tenting screw |
| horizontal bone augmentation using Double tenting screwParticipants in this group will receive guided bone regeneration (GBR) with two titanium bone screws for enhanced graft stabilization. One screw will be placed at the crestal level, while a second screw will be inserted 5 mm apical to the first, providing vertical stabilization of the graft material. The procedure involves sulcular and vertical releasing incisions, full-thickness flap elevation on both buccal and palatal/lingual aspects, and multiple cortical perforations to stimulate vascularization. The defect will be filled with particulate allograft extending 10-12 mm apicocoronally and covered with a bovine pericardium membrane. Tension-free primary closure will be performed using 5-0 polypropylene sutures. At 6 months, screws will be removed and dental implants placed. This intervention is distinguished by the dual-screw fixation technique, designed to provide greater mechanical stability compared to the single-screw approach used in the comparator group. | Procedure or surgery | Double tenting screw |
Primary outcome
Change in Horizontal Ridge Width at Mid-Crestal Level
Time frame: 6 months post-intervention
Ridge width will be measured at the mid-crestal level using a bone caliper to the nearest millimeter. A standardized stent will ensure consistent measurement positioning.
Change in Horizontal Ridge Width 5 mm Apical to Crest
Time frame: 6 months post-intervention
Ridge width will be measured 5 mm apical to the crestal level using a bone caliper to the nearest millimeter. The same stent will standardize measurements.
3 secondary outcomes
Change in Keratinized Mucosa Width at 6 Months Post-Reentry
Time frame: 6 months post-intervention
Change in Alveolar Ridge Width via CBCT at 6 Months
Time frame: 6 months post-intervention
Change in Bone Density via CBCT at 6 Months
Time frame: 6 months post-intervention
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 11 Jul 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing horizontal bone augmentation using single tenting screw and horizontal bone augmentation using Double tenting screw in people with Bone Defects, run by Omar Saad at 1 site in Egypt.
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 3 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 11 Jul 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 Egypt. 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?
Change in Horizontal Ridge Width at Mid-Crestal Level (time frame: 6 months post-intervention). 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 11 Jul 2025.