NCT07391384

Brief Summary

use of Thymoquinone hydrogel with bone graft in comparison to bone graft only around immediate implant-this hydrogel fill the jumping zone in comparison to using hydrogel bone graft only to increase primary stability and enhance osseointegration

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
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

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 21, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

January 21, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 10, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 11, 2026

Completed
Last Updated

February 5, 2026

Status Verified

January 1, 2026

Enrollment Period

20 days

First QC Date

January 21, 2026

Last Update Submit

January 29, 2026

Conditions

Keywords

immediate implantthymoquinonehydrogelbone graft

Outcome Measures

Primary Outcomes (1)

  • primary stability

    Evaluate the primary stability by osstell pre- and post-3-month during abutment placement, this meaure from 1-99 ISQ

    0, 3 months

Secondary Outcomes (2)

  • secondary outcomes

    baseline, 3 months, and 6 months

  • secondary outcome

    3 months and 6 months

Study Arms (2)

surgical implants will inserted immediately after teeth extraction with xenograft.

PLACEBO COMPARATOR

immediat implant placement with bone graft hydrogel

Procedure: group 1 xenograft hydrogel

study group

ACTIVE COMPARATOR

surgical placement of 22 implants will inserted immediately after teeth extraction, combined xenograft and TQ gel.

Procedure: immediat implant placement wit TQ and bone graft hydrogel placement around implant

Interventions

22 implants will inserted immediately after teeth extraction with xenograft.

Also known as: control group
surgical implants will inserted immediately after teeth extraction with xenograft.

22 implants will inserted immediately after teeth extraction, combined xenograft and TQ gel.

study group

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients ages more than 18 years old, Participants were chosen according to specific eligibility criteria, requiring them to be healthy individuals classified as ASA I by the American Society of Anesthesiologists.
  • Patients requiring extraction of posterior teeth with consequent immediate implant placement.
  • Indications for extraction included: non restorable teeth (posterior teeth), untreatable caries, endodontic failures, remaining roots, vertical fracture of the roots.
  • Natural teeth adjacent to the tooth to be extracted will required to have complete occlusal surfaces and be free from infections..
  • \. Patients will selected with a thick soft tissue phenotype and a minimum keratinized tissue width (KTW) of 2 mm.

You may not qualify if:

  • Pathologies or drugs that alter tissue integration with dental implants. 2- Head and neck radiation therapy. 3- Renal disease, bleeding disorders and anticoagulant therapy. 4- Pregnant females. 5- Patients with severe para-functional habits and unfavorable occlusion 6- Smokers. 7- Malaligned teeth and teeth with acute periapical pathosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • aya kamal

    lecturer of periodontology Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shaimaa Hamdy, lecturer of Periodontology

CONTACT

Turky, doctor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
All participants, investigators, surgeons, and outcomes investigator are masked
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study will include 44 immediate implants replacing non-restorable posterior teeth. The patients were randomly assigned in equal numbers to two groups using http://www.randomizer.org Group I (Control): 22 implants will be inserted immediately after tooth extraction with xenograft. Group II (Study): 22 implants will be inserted immediately after tooth extraction, combined with xenograft and TQ gel.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of periodontology

Study Record Dates

First Submitted

January 21, 2026

First Posted

February 5, 2026

Study Start

January 21, 2026

Primary Completion

February 10, 2026

Study Completion

April 11, 2026

Last Updated

February 5, 2026

Record last verified: 2026-01