Immediate Implant Placement With Subepithelial Connective Tissue Grafting and Probiotics

NCT07596758 | Not Yet Recruiting DMC

• 1 other identifier: KFSIRB200-1008
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

The present study aims to evaluate and compare the clinical, radiographic, and biological peri-implant tissue outcomes of platelet-rich fibrin versus probiotics as adjuncts to immediate implant placement combined with subepithelial connective tissue grafting in adults requiring single immediate implant placement.

Conditions

Dental Implant Failed

Outcome Measures

Primary Outcomes (1)

• evaluation of matrix metalloproteinase-8 (MMP-8) levels

  Biological assessment will be performed by collecting peri-implant sulcular fluid samples for evaluation of matrix metalloproteinase-8 (MMP-8) levels. After gentle removal of supragingival plaque, the peri-implant site will be isolated with cotton rolls and dried with mild air flow. Sterile PerioPaper strips will be inserted carefully into the peri-implant sulcus until slight resistance is encountered and left in place for 30 seconds. Any strip contaminated with blood or saliva will be discarded. The collected samples will be transferred to sterile Eppendorf tubes and stored until analysis. Quantitative assessment of MMP-8 will be carried out using a human MMP-8 ELISA kit according to the manufacturer's protocol.

  12-months

Study Arms (2)

platelet-rich fibrin group

EXPERIMENTAL

Immediate implant placement with subepithelial connective tissue grafting and adjunctive platelet-rich fibrin

Procedure: Platelet-Rich Fibrin

probiotics group

EXPERIMENTAL

Immediate implant placement with subepithelial connective tissue grafting and adjunctive probiotics

Procedure: Probiotics

Interventions

Platelet-Rich Fibrin PROCEDURE

platelet-rich fibrin will be prepared immediately before application using freshly drawn autologous venous blood and a standardized centrifugation protocol selected according to the equipment available in the study setting. The prepared PRF will be used as an adjunct to the immediate implant and subepithelial connective tissue grafting procedure according to the finalized protocol, either locally around the peri-implant site and/or in intimate relation to the grafted soft tissue to enhance healing and tissue maturation.

platelet-rich fibrin group

Probiotics PROCEDURE

Probiotics probiotics will be administered as an adjunct to the immediate implant and subepithelial connective tissue grafting The mode of delivery, dose, and duration will be standardized for all patients allocated to this group.

probiotics group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults aged 20 to 45 years.
• Systemically healthy patients eligible for implant surgery.
• Patients requiring extraction of a single non-restorable tooth indicated for immediate implant placement.
• Implant sites located in the maxillary esthetic or para-esthetic zone.
• Sites with sufficient apical and/or palatal bone to permit correct three-dimensional implant positioning and achieve adequate primary stability.
• Sites suitable for simultaneous subepithelial connective tissue grafting.
• Patients with acceptable oral hygiene and good compliance with periodontal and implant treatment.
• Patients willing to attend all follow-up visits and comply with study instructions.

You may not qualify if:

• Medically compromised patients or patients with systemic conditions that may contraindicate implant surgery or interfere with healing.
• Smokers.
• Pregnant or lactating women.
• Patients with uncontrolled periodontal disease or poor oral hygiene.
• Patients with acute infection at the intended implant site.
• Patients with insufficient bone volume preventing immediate implant placement with adequate primary stability.
• Patients with a history of head and neck radiotherapy or chemotherapy.
• Patients receiving bisphosphonates or other medications known to affect bone metabolism or soft tissue healing.
• Patients with parafunctional habits that may jeopardize implant stability or restorative success.
• Patients unwilling or unable to complete the follow-up period.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

faculty of dentistry, kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 214312, Egypt

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• walid elamrousy, phd

  Kafrelsheikh University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

walid elamrousy, Phd

CONTACT

01029552024; waled_hammed@den.kfs.edu.eg

Lamis OMER, bachelor

CONTACT

+249999005524; nour_hetata@den.kfs.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: outcome assessor is blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Periodontology Department Faculty of Oral and Dental Medicine,Kafrelsheikh University

Model Details: two parallel-arm randomized controlled clinical trial with allocation concealment

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: May 14, 2026
• Primary Completion (Estimated): May 20, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 12 months

Locations

EG (1)