NCT06254378

Brief Summary

Implant placement in deficient posterior maxilla is a challenging clinical situation that necessitates appropriate treatment options to restore this area.

  • Aim of the study: To compare allograft vs tenting technique in terms of implant stability and bone height.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 12, 2024

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2024

Completed
Last Updated

February 12, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 25, 2024

Last Update Submit

February 9, 2024

Conditions

Sinus; DentalImplant ComplicationSurgery-Complications

Outcome Measures

Primary Outcomes (1)

  • Implant stability

    implant stability quotient(ISQ) is the evaluation unit set to determine the correct isq\<60:low stability isq 60-65 : medium stability isq \>70: high stability stability of the implant, this module by means of a resonance frequency analysis (rfa) applied to the bone manages to measure stability on an isq scale from 1 to 100 (khz):

    During the implant placement procedure and after 6 months

Secondary Outcomes (1)

  • Bone hight

    Before surgery and after 6 months

Study Arms (2)

Sinus lifting without graft (control )

ACTIVE COMPARATOR

Patients will receive sinus lifting with immediate implant placement without graft placement.

Other: Sinus lifting without graft

Sinus lifting with graft (intervention)

EXPERIMENTAL

Patients will receive sinus lifting with immediate implant and allograft placement.

Procedure: Sinus lifting with allograft

Interventions

Sinus lifting with allograftPROCEDURE

Participants will receive sinus lifting and allograft with immediate implant in premolar-molar area.

Sinus lifting with graft (intervention)
Sinus lifting without graftOTHER

Participants will receive sinus lifting with immediate implant in premolar-molar area without graft

Also known as: Tenting technique
Sinus lifting without graft (control )

Eligibility Criteria

Age30 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient with missing upper pre molar , molar teeth
  • Patients in need of bone grafting of the maxillary sinus to house an implant.
  • Patients with residual alveolar crest of at least 3-4mm in height and 5mm in width distal to the canine as measured on CBCT scan
  • Patients with adequate inter-arch space

You may not qualify if:

  • Patients suffering from any sinus pathosis.
  • Patients who are heavy smokers (\>10 cigarettes/day).
  • Patient under psychiatric therapy or unrealistic expectations
  • Patients of systemic conditions that may interfere with carrying out the surgical procedure.
  • Lack of opposite occluding dentition/prosthesis in the area intended for implant placement
  • Severe bruxism or clenching
  • Poor oral hygiene (full mouth bleeding on probing and full mouth plaque index \>25%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Fouad W, Osman A, Atef M, Hakam M. Guided maxillary sinus floor elevation using deproteinized bovine bone versus graftless Schneiderian membrane elevation with simultaneous implant placement: Randomized clinical trial. Clin Implant Dent Relat Res. 2018 Jun;20(3):424-433. doi: 10.1111/cid.12601. Epub 2018 Mar 25.

    PMID: 29575547BACKGROUND

  • Karagah A, Tabrizi R, Mohammadhosseinzade P, Mirzadeh M, Tofangchiha M, Lajolo C, Patini R. Effect of Sinus Floor Augmentation with Platelet-Rich Fibrin Versus Allogeneic Bone Graft on Stability of One-Stage Dental Implants: A Split-Mouth Randomized Clinical Trial. Int J Environ Res Public Health. 2022 Aug 4;19(15):9569. doi: 10.3390/ijerph19159569.

    PMID: 35954926RESULT

MeSH Terms

Conditions

Fistula

Interventions

Transplantation, HomologousTransplantation

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Central Study Contacts

Amira R Elshikh, BCS

CONTACT

01068503398Amira.raafat2512@gmail.com

Salma H Abdelaty

CONTACT

0 111 399 9772

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

January 25, 2024

First Posted

February 12, 2024

Study Start

March 1, 2024

Primary Completion

September 30, 2024

Study Completion

October 30, 2024

Last Updated

February 12, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share