Peri-implant Tissue Changes Using Dual Zone Concept with Connective Tissue Graft Versus Concentrated Growth Factor
Launched by AIN SHAMS UNIVERSITY · Dec 6, 2024
Trial Information
Current as of October 04, 2025
Enrolling by invitation
Keywords
ClinConnect Summary
This is a random, controlled study comparing two ways to support soft tissue (the gums and surrounding tissue) when a front tooth is removed and a dental implant is placed right away in the upper jaw. Both groups use the same “dual zone” technique to protect gum and bone. One group uses a graft made from concentrated growth factor (CGF) placed in the area next to the labial bone, and the other group uses a connective tissue graft (CTG) taken from the palate. The study will measure how much the soft tissue volume changes, how good the final appearance looks (pink esthetic score), bone changes on imaging, and basic gum health, along with patient-reported pain, over about 6 months after the final crown is placed.
Eligible participants are adults aged roughly 20–50 who have a hopeless tooth in the upper front area and need extraction with immediate implant placement. They must be generally healthy, able to maintain good oral hygiene, and have enough bone to stabilize the implant (minimum torque of about 35 Ncm). Heavy smokers and pregnant or breastfeeding individuals are typically not eligible. The trial is taking place at Ain Shams University in Cairo, Egypt, and currently enrolling by invitation. Participants will be randomly assigned to CGF or CTG, with neither the participant nor the outcome assessors knowing which graft was used. They’ll have follow-ups with imaging, gum health checks, and a pain survey at several time points after surgery. The study aims to help clinicians decide which graft option may give the best cosmetic and tissue results around implants in the esthetic zone.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Systemically (medically) free individuals were recruited for the present study according to the modified Burkett's health history questionnaire, ASA.
- • Males and females with age range 20 - 50.
- • Patients having a history of hopeless tooth in esthetic zone (Anteriors/Premolars) indicated for extraction and immediate implant placement.
- • Patients who are cooperative and maintain proper oral hygiene.
- • Intact interproximal and palatal bone extending at least 6 mm apically, with sufficient apical bone to attain implant primary stability (a minimum of 35 Ncm insertion torque).
- Exclusion Criteria:
- • Heavy smokers. 20
- • Patients who exhibit parafunctional occlusal habits 21
- • Pregnant ladies or lactating mothers.
About Ain Shams University
Ain Shams University, established in Cairo, Egypt, is a prestigious higher education institution renowned for its commitment to academic excellence and research innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise in various medical and scientific disciplines to advance healthcare through rigorous research initiatives. With a focus on ethical practices and adherence to regulatory standards, Ain Shams University aims to contribute to the development of new therapies and improve patient outcomes, fostering collaboration among researchers, healthcare professionals, and industry partners in the pursuit of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cairo, Abbasia, Egypt
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported