NCT06962878

Brief Summary

Twenty recruited patients indicated for immediate implant placement in mandibular molar sites are divided into two groups, with each group containing ten patients. One group assigned for placement of xenograft after molar extraction and immediate implant placement, while the other group received allograft as space-filling material.

Trial Health

43
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 Aug 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

April 30, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

August 5, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2026

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2026

Completed
Last Updated

August 6, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

April 30, 2025

Last Update Submit

August 2, 2025

Conditions

Bone VolumeImmediate Implant With Bone Graft

Keywords

Bone graftJumping gapXenograftAllograftImmediate implant

Outcome Measures

Primary Outcomes (1)

  • Horizontal bone thickness in millimeters

    Two CBCT images will be taken, one immediately after surgery (baseline) and the other at 6 months post-surgically

    6 months postoperative

Secondary Outcomes (2)

  • Vertical bone height in millimeters

    6 months postoperative

  • Pain intensity

    One week postoperative

Study Arms (2)

Xenograft

ACTIVE COMPARATOR
Procedure: Xenograft

Allograft

EXPERIMENTAL
Procedure: Allograft

Interventions

XenograftPROCEDURE

The jumping gap and surrounding space will be augmented and packed with Xenograft

Xenograft
AllograftPROCEDURE

The jumping gap and surrounding space will be augmented and packed with Allograft

Allograft

Eligibility Criteria

Age25 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with non-restorable mandibular molars
  • Both sexes with age range from 25 years to 40 years
  • Good oral hygiene
  • Adequate alveolar bone dimensions for implant replacement
  • Adequate bone volume after extraction to achieve primary stability of the immediate implant
  • Co-operative patient

You may not qualify if:

  • Patients with any systemic disease as uncontrolled diabetes or osteoporosis
  • Heavy smokers with smokers more than 10 cigarettes per day
  • Pregnancy
  • Patients with any signs of active infection or pus formation
  • Patients undergoing chemotherapy or radiotherapy, immunocompromised patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (10)

  • Botticelli D, Berglundh T, Buser D, Lindhe J. The jumping distance revisited: An experimental study in the dog. Clin Oral Implants Res. 2003 Feb;14(1):35-42. doi: 10.1034/j.1600-0501.2003.140105.x.

    PMID: 12562363BACKGROUND

  • Bhola M, Neely AL, Kolhatkar S. Immediate implant placement: clinical decisions, advantages, and disadvantages. J Prosthodont. 2008 Oct;17(7):576-81. doi: 10.1111/j.1532-849X.2008.00359.x. Epub 2008 Aug 26.

    PMID: 18761580BACKGROUND

  • Lang NP, Pun L, Lau KY, Li KY, Wong MC. A systematic review on survival and success rates of implants placed immediately into fresh extraction sockets after at least 1 year. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:39-66. doi: 10.1111/j.1600-0501.2011.02372.x.

    PMID: 22211305BACKGROUND

  • Dimitriou R, Mataliotakis GI, Angoules AG, Kanakaris NK, Giannoudis PV. Complications following autologous bone graft harvesting from the iliac crest and using the RIA: a systematic review. Injury. 2011 Sep;42 Suppl 2:S3-15. doi: 10.1016/j.injury.2011.06.015. Epub 2011 Jun 25.

    PMID: 21704997BACKGROUND

  • Khoury F, Hanser T. Mandibular bone block harvesting from the retromolar region: a 10-year prospective clinical study. Int J Oral Maxillofac Implants. 2015 May-Jun;30(3):688-97. doi: 10.11607/jomi.4117.

    PMID: 26009921BACKGROUND

  • Schropp L, Isidor F. Timing of implant placement relative to tooth extraction. J Oral Rehabil. 2008 Jan;35 Suppl 1:33-43. doi: 10.1111/j.1365-2842.2007.01827.x.

    PMID: 18181932BACKGROUND

  • Alexopoulou M, Lambert F, Knafo B, Popelut A, Vandenberghe B, Finelle G. Immediate implant in the posterior region combined with alveolar ridge preservation and sealing socket abutment: A retrospective 3D radiographic analysis. Clin Implant Dent Relat Res. 2021 Feb;23(1):61-72. doi: 10.1111/cid.12974. Epub 2021 Jan 13.

    PMID: 33438320BACKGROUND

  • Howe MS, Keys W, Richards D. Long-term (10-year) dental implant survival: A systematic review and sensitivity meta-analysis. J Dent. 2019 May;84:9-21. doi: 10.1016/j.jdent.2019.03.008. Epub 2019 Mar 20.

    PMID: 30904559BACKGROUND

  • Adell R, Lekholm U, Rockler B, Branemark PI. A 15-year study of osseointegrated implants in the treatment of the edentulous jaw. Int J Oral Surg. 1981 Dec;10(6):387-416. doi: 10.1016/s0300-9785(81)80077-4.

    PMID: 6809663BACKGROUND

  • Kononen E, Gursoy M, Gursoy UK. Periodontitis: A Multifaceted Disease of Tooth-Supporting Tissues. J Clin Med. 2019 Jul 31;8(8):1135. doi: 10.3390/jcm8081135.

    PMID: 31370168BACKGROUND

Related Links

MeSH Terms

Interventions

Transplantation, HeterologousTransplantation, Homologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Study Officials

  • Mohamed Atef, PhD

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Ahmed Mohamed Tawfik, BSc

CONTACT

+201095544285ahmed-tawfik@dentistry.cu.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
This trial is considered a randomized single blind clinical trial due to the following: * The participants will be blinded to the technique that will be used during the surgical procedure. * The operator will not be blinded for both techniques during the surgical procedure as the two techniques are different. * The outcome assessor cannot be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dentist

Study Record Dates

First Submitted

April 30, 2025

First Posted

May 8, 2025

Study Start

August 5, 2025

Primary Completion

February 5, 2026

Study Completion

March 5, 2026

Last Updated

August 6, 2025

Record last verified: 2025-05

Locations

EG(1)