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CompletedNCT07001813Updated Jun 3, 2025

Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted After Xenograft Socket Preservation in Posterior Maxilla

An interventional study of socket preserved and non preserved socket in Implant Therapy, sponsored by Suez Canal University. Completed at 1 site in Egypt. Open to male participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-03.

Sponsored by Suez Canal University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 2 years 9 months after the study started (first participant enrolled Aug 2022, registered May 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
Male
01

Study summary

Clinical and Radiographic Assessment of the Outcomes of Dental Implant Inserted after Xenograft Socket Preservation in Posterior Maxilla: A Randomized Controlled Study

Read the detailed description

Dental implants have become a common choice among the treatment options for missing teeth rehabilitation and has remarkably high survival and success rates Since the introduction of implants into clinical practice more than several decades ago. The success rate of dental implants, over the last ten years, has been about 90- 95%.

Invasive and non-invasive clinical tests are available like histomorphometric analysis, radiographic analysis, push- and pull-out tests, percussion tests, Periotest and resonance frequency analysis (RFA) are employed to assess the steadiness of dental implants to assess objectively implant stability at different stages of its service life to verify successful implantation.

02

Conditions studied

  • Implant Therapy

Keywords

  • Implant
  • clinical stability
  • radiographic assessment
  • soft tissue health
03

In context

Lead sponsor

Suez Canal University is the lead sponsor of 157 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male patients aged between 21 and 40 years.
  • General good health.
  • Absence of any relevant systemic disease.
  • Presence of a hopeless maxillary posterior tooth that requires extraction.
  • Extraction site suitable for replacement by a dental implant.
  • Cases have adequate bone width and length.
  • Volunteer subjects must sign an informed consent.

Exclusion criteria

Exclusion Criteria:

  • Poor oral hygiene with no possibility of improvement.
  • Smokers (more than 10 cigarettes per day).
  • Chronic treatment with any medication known to affect oral status and bone turnover.
  • Drug or alcohol abuse.
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Active comparator
    socket preserved

    (8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.

    Device: socket preserved

  • Placebo comparator
    non preserved sockets

    (8 cases): was not exposed to any type of socket preservation after the extraction procedure.

    Device: non preserved socket

Interventions

  • Devicesocket preserved

    (8 cases): was treated by immediate socket preservation with S1-XB xenograft augmentation after extraction.

  • Devicenon preserved socket

    (8 cases): was not exposed to any type of socket preservation after the extraction procedure.

06

What researchers measure

Primary outcomes

  1. clinical assessment of primary stability of dental implant

    implant stability assessment by 1. rachet insertion torque * The implant was installed into the osteotomy site using the motorized method with the engine set at 50 rpm and 35-50 N/cm torque. * A ratchet was used to place the implant to the desired depth when the insertion torque was more than 35N/cm torque. 2. osstell device (ISQ) Make it possible to monitor osseointegration in a precise and objective manner. * Osstell helps to objectively and non-invasively determine implant stability. The prob attached to the instrument via a cable and measurements are displayed on the black lit display. * The device held in a right angle to the center toward the implant to be examined, the maximum deviation angle from the orthoradial direction of percussion is 45 degrees. In addition, the rod and the test surface must maintain 0.6-2.5 mm distance according to the operating instructions. * The implant stability using OSTELL device was taken immediately postoperative and was assessed after 4 months

    Time frame: immediately and after four months • A ratchet was used to place the implant immediately The implant stability using OSTELL device was taken immediately postoperative implant insertion and was assessed after 4 months before prothesis

  2. radiographic assessment of implant stability

    1. Pre-operative radiographic evaluation: After a healing period of four months, all the patients evaluated by Scanora 3D Cone Beam Computed Tomography scanner (CBCT) for evaluation bucco-lingual dimention, mesio-distal width, relation to neighbouring vital structures, bone density and assessment good position for implant placement. Post-operative Digital Radiography Assessment: 2. Intra oral paralleling periapical direct digital radiographic procedure: Indirect Standardized digital radiographs were achieved using KaVo Scan eXam™M One and the Rinn extension cone paralleling (XCP) periapical film holder. The KaVo Scan eXam™M One is an Intraoral digital imaging plate system (psp) system using Imaging plate which is a film-like thin, flexible, and wireless phosphorescent plate, which works as a wireless receptor.

    Time frame: 1.Pre-operative radiographic evaluation: before implant placement 2.Intra oral paralleling periapical direct digital radiographic procedure: immediately after placement and after four months

07

Study locations

1 site
  • faculty of dentistry Suez canal university
    Ismailia, Egypt
08

References and documents

Publications

  • AAl MA, El Far M, Sheta NM, Fayyad A, El Desouky E, Nabi NA, Ibrahim M. Correlation of Implant Stability Between Two Noninvasive Methods Using Submerged and Nonsubmerged Healing Protocols: A Randomized Clinical Trial. J Oral Implantol. 2020 Dec 1;46(6):571-579. doi: 10.1563/aaid-joi-D-19-00130. PubMed 33494103 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07001813
Lead sponsor
Suez Canal University
Responsible party
Sponsor
First posted
Jun 3, 2025
Start date
Aug 1, 2022
Primary completion
Aug 1, 2024
Completion
Dec 1, 2024
Last update
Jun 3, 2025

Study contacts

mohamed kamel Attia, postgraduate student
principal investigator · Suez Canal University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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