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Status unknownNCT05431998Updated Jun 24, 2022

Evaluation of Autogenous Demineralized Tooth Graft Versus Autogenous Bone Graft During Immediate Implant Placement in the Esthetic Zone.

An interventional study of the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement and the use of autogenous bone graft in the jumping gap during immediate implant placement in Estetic Zone, Autogenous Tooth Graft and Autogenous Bone Graft, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-06-24.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

To compare the use of demineralized autogenous tooth graft versus autogenous bone graft, in the jumping gap in immediate implant placement with immediate loading.

Read the detailed description

Immediate implant placement was introduced in 1978, using a ceramic implant made of Al2O3. Ever since then it has become one of the most successful treatment options to maintain the alveolar bone after tooth extraction, showing success rate of more than 95%. Continuous research and development of immediate implant techniques keep being introduced, stemming from the fact that immediate implant placement is a safe, predictable, and favorable solution after the loss of a tooth.

A 2 mm jumping gap is recommended in the treatment guidelines proposed in an ITI Consensus Conference. This provides sufficient space to fill the bone defect between the exposed implant surface and the facial bone wall with an appropriate bone filler. A gap in these dimensions also provides a space for the formation of a blood clot which can subsequently reorganize into a provisional connective tissue matrix and support the formation of newly formed woven bone. This was demonstrated in a preclinical study in which a wider defect and bone wall dimension were associated with less crestal bone height reduction and more bone to implant contact than a narrower defect and bone wall dimension. Also, immediate placement with a dual-zone augmentation technique, and a socket seal technique utilizing a prefabricated shell made of acrylic and immediate restoration, out of occlusion showed very promising results.

The addition of graft material during immediate implant placement is very common and useful in many cases. Autogenous bone graft is considered to be the gold standard graft material, which makes comparing new graft materials to it sensible. Still, tooth bone graft has been used numerous of times for socket preservation, and it shows good results.

02

Conditions studied

  • Estetic Zone
  • Autogenous Tooth Graft
  • Autogenous Bone Graft
  • Immediate Implant
  • Jumping Gap
  • Crestal Bone Level
03

In context

Lead sponsor

Cairo University is the lead sponsor of 4,780 studies on the registry; 1,427 are open to participants now.

Of its 36 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

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

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Patients in need of extraction of a single, un-restorable tooth in the esthetic zone (Maxillary anteriors and premolars). Only one implant per patient.

An intact buccal plate of bone, or minimally affected. Jumping gap ≥ 2mm . Age 18-60. Medically free patients.

Exclusion criteria

Exclusion Criteria:

  • Restorable teeth. Teeth with severely damaged or no remaining buccal plate. Acute infection in the implant site. Patients with an insufficient bone to obtain primary stability. Patients in need of sinus bone grafting. A systemic condition that affects bone healing (e.g., diabetes mellitus or bone disease).

Smokers. Poor oral hygiene. Patient with a physical disability that hinders the upkeep of good oral hygiene measures.

Any general contraindication to oral surgery. Participants suffering from diseases that may affect bone or soft tissue healing.

A participant who had radiotherapy or chemotherapy. Psychiatric patient, or with a learning disability, or unable to give consent. Pregnant and nursing women

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    The use of demineralized autogenous tooth graft in the jumping gap of the immediate implant

    The participant's own freshly extracted tooth will be cleaned from periodontal ligaments, cementum, soft tissue attachment, caries, or restorations (if present) and have their crown decapitated, using a high-speed fine finishing stone and saline irrigation. The pulp chamber and root pulp will be cleaned by split opening the root and cleaning it out using a high-speed diamond bur. Subsequently, teeth will be ground, and demineralized using a hand bone mill (Gold Bone Mill, MCT Bio, Korea). Then the particles will be prepared by demineralization of tooth particles in 0.6N hydrochloric acid (Chemajet Chemicals, Egypt) for 30 min then washed twice in saline and dried with sterile gauze. Then it will be used as a graft for the bone defect around the immediately placed implant.

    Procedure: the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement

  • Active comparator
    The use of autogenous bone graft in the jumping gap of the immediate implant

    A horizontal vestibular incision will be placed below the mucogingival junction and a mucoperiosteal flap will be reflected then autogenous bone particles will be collected from the participants using Automatic Bone Collector Bur (ACM Bur) by NeoBiotch, from the mandibular retro-molar region, speed 300rpm, torque 30Ncm, with irrigation.

    Procedure: the use of autogenous bone graft in the jumping gap during immediate implant placement

Interventions

  • Procedurethe use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement

    the use of demineralized autogenous tooth graft in the jumping gap during immediate implant placement

  • Procedurethe use of autogenous bone graft in the jumping gap during immediate implant placement

    the use of autogenous bone graft in the jumping gap during immediate implant placement

06

What researchers measure

Primary outcomes

  1. Marginal bone level

    Marginal bone level: The bone level will be measured from the implant shoulder to the first bone-implant contact, from all 4 surfaces (mesial, distal, buccal, and lingual/palatal), measured by CBCT scans.

    Time frame: 9 months

Secondary outcomes

  1. post operative pain

    Visual analog scale (0-10)

    Time frame: 2 weeks

  2. Implant sucess

    Based on the criteria of Albrektsson, Zarb, Worthington, and Eriksson(1986) and of Buser, Weber and Lang(1990). The following are the criteria for implant success: the absence of mobility, the absence of acute or chronic peri-implant infection, the absence of radiolucency around the implant, without pocket probing depth (PPD) ≧ 5 mm, and without vertical bone loss ≧ 1.5 mm in the first year. The cases will be defined as a failure if they can't reach any one of the success criteria

    Time frame: 12 months

  3. Pink esthetic score

    The PES includes seven variables: the mesial papilla, distal papilla, midfacial level, midfacial contour, alveolar process deficiency, soft tissue color, and soft tissue texture. Each variable was evaluated with a 0-1-2 score, with 2 being the best and 0 being the worst. Thus, the highest total score was 14. The mesial and distal papillae were assessed for completeness. All other variables were evaluated by comparison with the contralateral tooth. The threshold of an acceptable PES was 8. Scores of 12 or more indicated a nearly perfect outcome

    Time frame: 12 months

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05431998
Lead sponsor
Cairo University
Responsible party
Ahmed Taha Taha Ahmed (Dentist, Cairo University) — Principal investigator
First posted
Jun 24, 2022
Start date
Jul 1, 2022 (estimated)
Primary completion
Aug 30, 2022 (estimated)
Completion
Aug 1, 2023 (estimated)
Last update
Jun 24, 2022

Study contacts

Ahmed T Taha, BDS
Contact
ahmed-taha@dentistry.cu.edu.eg
00201026776111
Karim M Fawzy, PhD
study chair · Cairo University
Nesma M Shemais, PhD
study director · Cairo University
Rahma H Ahmed, BDS
principal investigator · Cairo University
Ahmed T Taha, BDS
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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