NCT07825896

Brief Summary

Background: Teeth loss in the posterior mandible initiates residual ridge resorption, this causes difficulty in implant placement so ridge augmentation must be done either simultaneous with implant placement or in a staged approach Aim: To evaluate the effect of autogenous sticky bone with PRF membrane and xenograft with collagen membrane with simultaneous implant placement clinically on primary and secondary implant stability, and radiographically on bucco-lingual width gain, bone density and crestal bone loss

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
9mo left

Started Sep 2026

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

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Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Jun 2027

First Submitted

Initial submission to the registry

September 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
8 days until next milestone

Study Start

First participant enrolled

September 25, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

9 months

First QC Date

September 13, 2026

Last Update Submit

September 13, 2026

Conditions

Ridge Augmentation

Outcome Measures

Primary Outcomes (4)

  • Change in implant stability

    Implant stability will be recorded immediately after placement (1ry stability) and after 6 months (2ry stability ) by using osstell device. The result is presented in form of ISQ value from 1 to 100, the higher the ISQ the higher the stability of implant

    up to 6 months

  • change in bucco-lingual bone thickness

    All participants in the study will be advised to undergo CBCT before implant placement to measure bucco-lingual bone thickness, and again 7 days postoperatively and 6 months after implant placement to assess the following.

    up to 6 months

  • change in marginal bone level

    At buccal, lingual, mesial, and distal sites will be evaluated radiographically from the shoulder of the implant to the alveolar crest. The mean marginal bone loss after the placement of implants will be calculated by subtracting baseline value from the values obtained at 6 and 9 months post implant placement

    up to 9 months

  • change in ridge width

    Will be measured immediately and after 6 months, bone width will be measured for each implant at three levels (2, 5, and 10 mm from the alveolar crest) and the mean will be calculated for each implant at each time interval.

    up to 6 months

Secondary Outcomes (3)

  • change in pain scores

    up to 7 days

  • change in edema scores

    up to 7 days

  • change in bone density

    up to 6 months

Study Arms (2)

Test Group

EXPERIMENTAL
Other: autogenous sticky bone + PRF membrane

Control Group

ACTIVE COMPARATOR
Other: Xenograft + collagen membrane

Interventions

autogenous sticky bone + PRF membraneOTHER

Patients in this group will be treated using autogenous sticky bone with PRF membrane.

Test Group
Xenograft + collagen membraneOTHER

Patients in this group will be treated using a xenograft with a collagen membrane.

Control Group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with missing posterior mandibular teeth.
  • Horizontal bone defect with width \< 5.5 mm.
  • Adequate zone of keratinized tissue

You may not qualify if:

  • Presence of infection or periapical lesions in adjacent teeth.
  • Medically compromised patients with a condition that affects the procedure.
  • Insufficient inter-arch distance.
  • Bruxism or clenching.
  • Alcoholism.
  • Heavy Smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Alexandria, Azarita, 00203, Egypt

Location

MeSH Terms

Interventions

Transplantation, Heterologous

Intervention Hierarchy (Ancestors)

TransplantationSurgical Procedures, Operative

Central Study Contacts

Mohamed Essam, BDS

CONTACT

01225710437mohamedessam2363@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 17, 2026

Study Start

September 25, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Locations

EG(1)