NCT07368621

Brief Summary

A stable soft and hard tissues around Osseo-integrated implants are very crucial. Soft tissue thickness around implants is crucial as it prevents peri-implant bone loss and enhance the esthetic outcomes. The treatment of thin tissue phenotype should be improved as the thin tissue phenotype will lead to plaque accumulation. There are some techniques that can increase the thickness of the peri-implant mucosa including connective tissue graft, platelet- rich fibrin and xenogeneic collagen matrix .Leukocyte and Platelet rich fibrin is a second generation platelet concentrate that was introduced by choukroun et al in 2001 after platelet rich plasma. PRF is the first source of autogenous blood derived growth factors harvested without the use of anticoagulants5. It contains various growth factors that are believed to contribute to periodontal regeneration. It promotes neovascularization and accelerated wound closing

Trial Health

77
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
3mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress58%
Jan 2026Jul 2026

Study Start

First participant enrolled

January 16, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

7 months

First QC Date

January 20, 2026

Last Update Submit

January 20, 2026

Conditions

Soft Tissue Thickness Around Delayed Implants in Patients With Thin Gingival Phenotype

Keywords

CTGL-PrfSoft tissue thickness

Outcome Measures

Primary Outcomes (1)

  • Gingival thickness

    Anesthetic needle with a rubber stopper36 Numerical (mm)

    6 months

Secondary Outcomes (2)

  • Postoperative pain (direct)

    14 days

  • Width of keratinized mucosa

    6 months

Study Arms (2)

Control group

OTHER

Connective tissue graft (CTG)

Procedure: Connective tissue graft(CTG)

Test group

ACTIVE COMPARATOR

Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)

Procedure: Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)

Interventions

Connective tissue graft(CTG)PROCEDURE

A harvested connective tissue graft will be placed in the prepared muco-periosteal flap around the implant. The graft will be adapted and secured in place using horizontal matrices.

Control group
Connective tissue graft (CTG) + leukocyte platelet-rich fibrin (L-PRF)PROCEDURE

To prepare the L-PRF, a 10 ml of blood will be drawn from the antecubital vein of the patient's right or left arm and will be transferred to the free anticoagulant test-tube. The blood sample will be immediately centrifuged at 2700 rpm for 12 minutes33. L-PRF will be applied over the connective tissue graft in the prepared mucoperiosteal flap around the implant34. Then the graft will be secured with horizontal mattresses with an absorbable vicryl 6-0. A non-absorbable prolene suture will be used to approximate the flap.

Test group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \. Patients between 18-60 years. 2. With thin gingival phenotype with a peri-implant mucosal thickness of less than 2mm28. With single missing tooth in the incisor, canine and premolar area. With the presence of two natural adjacent teeth and to not have a bone augmentation procedure before or during the dental implant.
  • \. Patient consent approval and signing 4. Medically free patients 5. Patients with good oral hygiene 6. Patients free from untreated periodontal disease

You may not qualify if:

  • \. Smokers 2. Psychological problem 3. Pregnancy 4. Systemic disease 5. Poor oral hygiene 6. Patients who previously received radiation therapy of the jaws 7. Patients taking medications that affect healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The British University in Egypt

Cairo, Cairo Governorate, 11837, Egypt

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Biostatican
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator

Study Record Dates

First Submitted

January 20, 2026

First Posted

January 26, 2026

Study Start

January 16, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

EG(1)