Bone Loss in JawNCT06468592

Implantation in Posterior Maxilla in Cases With Insufficient Bone

A study testing Tilted insertion of implants and Straight insertion of implants in people with Bone Loss in Jaw and Implant Site Reaction, run by Damascus University at 1 site in Syria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Dental implant procedures are performed on two groups of individuals who share the common characteristic of insufficient bone for traditional implantation. The first group lacks a palatal process, while the second group has a palatal process. Read more about this study

Who is it for?: Ages 32 to 73 years
Conditions the study is for: Bone Loss in Jaw, Implant Site Reaction
What is being tested?: Tilted insertion of implants and Straight insertion of implants
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteSyria
Study dates: 2 Mar 2022to 28 Jun 2023
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 32 to 73 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have inadequate bone density in the posterior region of the upper jaw.
Patients should maintain good oral hygiene.
The surgical site must be free from infection.
There should be no contraindications for oral surgery.
For the first group:
Patients in the first group must have a palatal process of the maxillary bone determined by radiographic examination.

Who cannot join

Patients with adequate bone volume to receive an implant.
Patients with systemic diseases that impair metabolism or healing at the surgical site.
Patients with contraindications for surgery, including cardiovascular disorders, blood clotting disorders, anticoagulant use, or uncontrolled diabetes.
Patients receiving medications that affect bone metabolism, such as corticosteroids, oral contraceptives, hormonal treatments, or those undergoing chemical or radiological therapies.

Trial locations and contacts

1 site in 1 country.

Syria1 site

Orthodontics Department, Faculty of Dentistry, University of Aleppo
Aleppo

Other trials in Syria

About this study

Official title: Implantation in the Palatal Process of the Maxilla as a Modification of the Osteotome Sinus Floor Elevation (Summers Technique)

Dental implant procedures are performed on two groups of individuals who share the common characteristic of insufficient bone for traditional implantation.

The first group lacks a palatal process, while the second group has a palatal process. Then, compare the initial primary stability of implants in the maxillary bone-type (D4) that were inserted tilted in the palatal process of the maxilla, palatally from the maxillary sinus, with implants inserted axially into the maxillary sinus by using a manual torque wrench.

Read the detailed description

Increasing the initial primary stability intensity value increases the success rate of implants in general and also allows immediate or early loading procedures to begin. In addition, to avoid complications resulting from inserting implants into the compromised maxillary sinus according to the Summers method. The most important of these is perforation of the mucous membrane lining the maxillary sinus and the possibility of its application in pathological cases of the maxillary sinus, such as chronic maxillary sinusitis and the presence of mucous retention cysts, in which intervention according to the usual Summers method is not indicated.

Despite the previous advantages obtained by this method, there are some disadvantages to the technique of tilting the implants in the palatal direction from the maxillary sinus, which are the limitation of its application to cases with a palatal process of the maxilla in the upper jawbone, which requires performing a three-dimensional radiograph. It was observed in this study and after studying the cross-sections that sufficient thickness for this process was less likely present than in cases of its absence. In addition, prosthetic procedures are generally difficult in tilted implants compared to axial implants.

Conditions: Bone Loss in Jaw, Implant Site Reaction
Being tested: Tilted insertion of implants, Straight insertion of implants

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tilted insertion of implantsProcedure or surgery
Using osteotomes, implants are inserted and tilted from 30° to 45° into the palatal direction from the maxillary sinus.
Straight insertion of implantsProcedure or surgery
The implants are inserted in an axial direction into the maxillary sinus according to Summers' traditional technique.

Study groups in NCT06468592
Study group	Role	What they receive
Tilted implants	Experimental	The tilted implants are inserted palatally into the maxillary sinus Receives: Procedure: Tilted insertion of implants
Straight implants	Active comparator	The implants inserted into the maxillary sinus in an axial direction Receives: Procedure: Straight insertion of implants

What is being measured

The primary outcome is the main question the study is designed to answer.

The initial implant stability
Primary stability was recorded for all implants in both groups, estimated by Newton/cm (N/cm), using a manual torque wrench.
This manual measure consists of a fixed arm installed above the implants and a moving arm moving away from the fixed arm in a clockwise direction, graduating from 5-45 Newtons. When the moving arm stops, the distance between it and the fixed arm expresses the first degree of the initial primary stability.
Measured: one time assessment at five minutes following the completion of inserting implants.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Mar 202228 Jun 2023

First posted21 Jun 2024
Study start2 Mar 2022
Primary completion15 Jan 2023
Study completion28 Jun 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Bone Loss in JawStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06468592
Sponsor's protocol ID: UDDS-OMFS-1-2024
Status last verified: Jun 2024
First submitted: 15 Jun 2024
Last updated: 21 Jun 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Summers RB. The osteotome technique: Part 2--The ridge expansion osteotomy (REO) procedure. Compendium. 1994 Apr;15(4):422, 424, 426, passim; quiz 436.
PubMed 8055514
Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.
PubMed 7994726
Summers RB. The osteotome technique: Part 4--Future site development. Compend Contin Educ Dent. 1995 Nov;16(11):1090, 1092 passim; 1094-1096, 1098, quiz 1099.
PubMed 8598008
Boyne PJ. Analysis of performance of root-form endosseous implants placed in the maxillary sinus. J Long Term Eff Med Implants. 1993;3(2):143-59.
PubMed 10146541
Del Fabbro M, Ceresoli V. The fate of marginal bone around axial vs. tilted implants: a systematic review. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S171-89.
PubMed 24977252
Barnea E, Tal H, Nissan J, Tarrasch R, Peleg M, Kolerman R. The Use of Tilted Implant for Posterior Atrophic Maxilla. Clin Implant Dent Relat Res. 2016 Aug;18(4):788-800. doi: 10.1111/cid.12342. Epub 2015 Apr 8.
PubMed 25853626
Malo P, de Araujo Nobre M. Partial rehabilitation of the posterior edentulous maxilla using axial and tilted implants in immediate function to avoid bone grafting. Compend Contin Educ Dent. 2011 Nov-Dec;32(9):E136-45.
PubMed 23627307
Penarrocha-Oltra D, Candel-Marti E, Ata-Ali J, Penarrocha-Diago M. Rehabilitation of the atrophic maxilla with tilted implants: review of the literature. J Oral Implantol. 2013 Oct;39(5):625-32. doi: 10.1563/AAID-JOI-D-11-00068. Epub 2011 Nov 28.
PubMed 22121829
Bruschi E, Manicone PF, De Angelis P, Papetti L, Pastorino R, D'Addona A. Comparison of Marginal Bone Loss Around Axial and Tilted Implants: A Retrospective CBCT Analysis of Up to 24 Months. Int J Periodontics Restorative Dent. 2019 Sep/Oct;39(5):675-684. doi: 10.11607/prd.4110.
PubMed 31449578

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implantation in the Palatal Process of the Maxilla as a Modification of the Osteotome Sinus Floor Elevation (Summers Technique)
ClinicalTrials.gov ID: NCT06468592
Acronym / sponsor ID: UDDS-OMFS-1-2024
Conditions: Bone Loss in Jaw, Implant Site Reaction
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: Damascus UniversityUniversity, hospital or other
Study start: 2 Mar 2022 (actual)
Primary completion: 15 Jan 2023 (actual)
Study completion: 28 Jun 2023 (actual)
First posted: 21 Jun 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.

Dental implant procedures are performed on two groups of individuals who share the common characteristic of insufficient bone for traditional implantation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Tilted implants	Experimental	Procedure: Tilted insertion of implantsThe tilted implants are inserted palatally into the maxillary sinus
Straight implants	Active comparator	Procedure: Straight insertion of implantsThe implants inserted into the maxillary sinus in an axial direction

Who may qualify

Ages: 32 to 73 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients must have inadequate bone density in the posterior region of the upper jaw.
Patients should maintain good oral hygiene.
The surgical site must be free from infection.
There should be no contraindications for oral surgery.
Patients in the first group must have a palatal process of the maxillary bone determined by radiographic examination.

Key exclusion criteria (4 listed)

Patients with adequate bone volume to receive an implant.
Patients with systemic diseases that impair metabolism or healing at the surgical site.
Patients with contraindications for surgery, including cardiovascular disorders, blood clotting disorders, anticoagulant use, or uncontrolled diabetes.
Patients receiving medications that affect bone metabolism, such as corticosteroids, oral contraceptives, hormonal treatments, or those undergoing chemical or radiological therapies.

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
Tilted insertion of implantsUsing osteotomes, implants are inserted and tilted from 30° to 45° into the palatal direction from the maxillary sinus.	Procedure or surgery	Tilted implants
Straight insertion of implantsThe implants are inserted in an axial direction into the maxillary sinus according to Summers' traditional technique.	Procedure or surgery	Straight implants

Primary outcome

The initial implant stability
Time frame: one time assessment at five minutes following the completion of inserting implants.
Primary stability was recorded for all implants in both groups, estimated by Newton/cm (N/cm), using a manual torque wrench. This manual measure consists of a fixed arm installed above the implants and a moving arm moving away from the fixed arm in a clockwise direction, graduating from 5-45 Newtons. When the moving arm stops, the distance between it and the fixed arm expresses the first degree of the initial primary stability.

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 21 Jun 2024.
Background: PubMed 8055514Summers RB. The osteotome technique: Part 2--The ridge expansion osteotomy (REO) procedure. Compendium. 1994 Apr;15(4):422, 424, 426, passim; quiz 436.
Background: PubMed 7994726Summers RB. The osteotome technique: Part 3--Less invasive methods of elevating the sinus floor. Compendium. 1994 Jun;15(6):698, 700, 702-4 passim; quiz 710.
Background: PubMed 8598008Summers RB. The osteotome technique: Part 4--Future site development. Compend Contin Educ Dent. 1995 Nov;16(11):1090, 1092 passim; 1094-1096, 1098, quiz 1099.
Background: PubMed 10146541Boyne PJ. Analysis of performance of root-form endosseous implants placed in the maxillary sinus. J Long Term Eff Med Implants. 1993;3(2):143-59.
Background: PubMed 24977252Del Fabbro M, Ceresoli V. The fate of marginal bone around axial vs. tilted implants: a systematic review. Eur J Oral Implantol. 2014 Summer;7 Suppl 2:S171-89.
Background: PubMed 25853626Barnea E, Tal H, Nissan J, Tarrasch R, Peleg M, Kolerman R. The Use of Tilted Implant for Posterior Atrophic Maxilla. Clin Implant Dent Relat Res. 2016 Aug;18(4):788-800. doi: 10.1111/cid.12342. Epub 2015 Apr 8.
Background: PubMed 23627307Malo P, de Araujo Nobre M. Partial rehabilitation of the posterior edentulous maxilla using axial and tilted implants in immediate function to avoid bone grafting. Compend Contin Educ Dent. 2011 Nov-Dec;32(9):E136-45.
Background: PubMed 22121829Penarrocha-Oltra D, Candel-Marti E, Ata-Ali J, Penarrocha-Diago M. Rehabilitation of the atrophic maxilla with tilted implants: review of the literature. J Oral Implantol. 2013 Oct;39(5):625-32. doi: 10.1563/AAID-JOI-D-11-00068. Epub 2011 Nov 28.
Background: PubMed 31449578Bruschi E, Manicone PF, De Angelis P, Papetti L, Pastorino R, D'Addona A. Comparison of Marginal Bone Loss Around Axial and Tilted Implants: A Retrospective CBCT Analysis of Up to 24 Months. Int J Periodontics Restorative Dent. 2019 Sep/Oct;39(5):675-684. doi: 10.11607/prd.4110.
Individual participant dataSharing planned: No

Related trials for Bone Loss in Jaw

Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
RecruitingObservational study
Immediate Molar Implants With Customized Healing Abutments in Different Post-Extraction Socket Classes
Tooth Loss, Alveolar Bone Loss
Enrolling by invitation
Odontogenic Graft Obtained From Human Tooth and Low Level Laser Therapy
Laser Therapy, Periodontal Diseases
Active, not recruiting
A Follow-Up Study of Straight and Tapered Dental Implants in the Front Upper Jaw
Tooth Loss in the Anterior Maxilla, Partial Edentulism of the Maxilla
Active, not recruiting
Radiographic Evaluation of Bone Level Evaluation Around Implants in All on Four Hybrid OT Restorations With Different Number of Screws
Bone Loss in Jaw

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 Tilted insertion of implants and Straight insertion of implants in people with Bone Loss in Jaw and Implant Site Reaction, run by Damascus University at 1 site in Syria.

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 4 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 21 Jun 2024. 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 Syria. 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?

The initial implant stability (time frame: one time assessment at five minutes following the completion of inserting implants.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06468592, which also lists 9 linked publications.

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 21 Jun 2024.