NCT06871475

Brief Summary

the main goal of this clinical trial is to evaluate the effect of sticky bone with coronally advanced flap in management of gingival recession in comparison to coronally advanced flap alone

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2025

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 4, 2025

Last Update Submit

March 7, 2025

Conditions

Gingival Recession, Localized

Outcome Measures

Primary Outcomes (2)

  • recession depth

    is measured from CEJ to the gingival margin in millimeters.

    changes in millimeters from base line up to 6 months

  • thickness of keratinized gingiva

    thickness of the keratinized gingiva in the faciolingual direction (gingival biotype)

    changes in biotype in millimeters from base line to follow up after 6 months

Secondary Outcomes (4)

  • Recession Width

    changes in millimeters from base line to follow up after 6 months

  • the height of keratinized gingiva

    changes in millimeters from base line up to 6 months

  • percentage of root coverage

    changes in percentile from base line up to 6 months

  • Probing pocket depth

    changes in millimeters from base line up to 6 months

Study Arms (2)

study group

EXPERIMENTAL

participant will receive sticky bone with coronally advanced flap

Biological: sticky bone with coronally advanced flap

control group

ACTIVE COMPARATOR

participants will undergo coronally advanced flap in treating gingival recession

Procedure: coronally advanced flap

Interventions

sticky bone with coronally advanced flapBIOLOGICAL

using sticky bone with coronally advanced flap in treating the gingival recession

study group
coronally advanced flapPROCEDURE

using coronally advanced flap alone in treating gingival recession

control group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Selected patients of both sexes with age range 25-45 years old.
  • Patients are systemically healthy based on questionnaire dental modification of Cornell index.
  • O'Leary index (1972) is less than 10% (the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation).
  • Buccal recession defects are classified RT1 according to Cairo's classification (2011).
  • Clinical indication and/or patient request for recession coverage.

You may not qualify if:

  • Pregnant female.
  • Smokers.
  • Patients with special needs or with any mental problems.
  • All patients are using any kind of medications that could interfere with healing of periodontal tissues. Such as chemotherapy and radiotherapy.
  • Teeth with carious lesions.
  • Rotated and extruded teeth.
  • Patient undergone any prior periodontal surgery in the relevant region within year.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minia University

Minya, Minya Governorate, 61511, Egypt

Location

Related Publications (10)

  • Ogata Y, Bui M, Griffin TJ, Hur Y. Use of Allograft with Platelet Concentrate in the Treatment of Multiple Miller Class III Gingival Recession Defects: Report of Three Cases. Int J Periodontics Restorative Dent. 2017 May/Jun;37(3):339-344. doi: 10.11607/prd.2673.

    PMID: 28402343RESULT

  • Wang HL, Kimble K, Eber R. Use of bone grafts for the enhancement of a GTR-based root coverage procedure: a pilot case study. Int J Periodontics Restorative Dent. 2002 Apr;22(2):119-27.

    PMID: 12019707RESULT

  • Sohn, D., B, H., J, K., Park WE, & Park CC. (2015). Utilization of autologous concentrated growth factors (CGF) enriched bone graft matrix(Sticky bone) and CGF-enriched fibrin membrane in implant dentistry. Jr Implant Adv Cli Dent.

    RESULT

  • Mathur A, Jain M, Jain K, Samar M, Goutham B, Swamy PD, Kulkarni S. Gingival recession in school kids aged 10-15 years in Udaipur, India. J Indian Soc Periodontol. 2009 Jan;13(1):16-20. doi: 10.4103/0972-124X.51889.

    PMID: 20376235RESULT

  • Louis F. Rose, D. M. (2006). Surgical Therapies for the Treatment of Gingival Recession. Inside dentistry.

    RESULT

  • Kimble KM, Eber RM, Soehren S, Shyr Y, Wang HL. Treatment of gingival recession using a collagen membrane with or without the use of demineralized freeze-dried bone allograft for space maintenance. J Periodontol. 2004 Feb;75(2):210-20. doi: 10.1902/jop.2004.75.2.210.

    PMID: 15068108RESULT

  • Hadziabdic, N. (2022). PRF and Sticky Bone as Regenerative Materials in Oral Surgery. IntechOpen. doi:10.5772/intechopen.108807

    RESULT

  • Ghoderao D, Rathod S, Kolte AP, Bawankar P, Jadhav A. Randomized, controlled clinical trial to evaluate efficacy of sticky bone and concentrated growth factor in the management of intrabony defects: 12 months follow-up study. Dent Res J (Isfahan). 2022 Aug 16;19:67. eCollection 2022.

    PMID: 36159047RESULT

  • Kapa BP, N K S, G V G, Mehta DS. Coronally Advanced Flap Combined With Sticky Bone and i-PRF-Coated Collagen Membrane to Treat Single Maxillary Gingival Recessions: Case Series. Clin Adv Periodontics. 2022 Sep;12(3):147-151. doi: 10.1002/cap.10164. Epub 2021 May 15.

    PMID: 33938633RESULT

  • Chatterjee A, Sharma E, Gundanavar G, Subbaiah SK. Treatment of multiple gingival recessions with vista technique: A case series. J Indian Soc Periodontol. 2015 Mar-Apr;19(2):232-5. doi: 10.4103/0972-124X.145836.

    PMID: 26015680RESULT

MeSH Terms

Conditions

Gingival Recession

Condition Hierarchy (Ancestors)

Gingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesPeriodontal Atrophy

Study Officials

  • Mohamed AbdElmonem Ebrahem, Professor

    Minia University

    STUDY CHAIR

  • Ahmed Abdallah Khalil, professor

    Minia University

    STUDY CHAIR

  • AyaAllah Kamal Abd El-al, lecturer

    Minia University

    STUDY DIRECTOR

  • Shaimaa Mohamed Ibrahim

    Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

shaimaa mohamed ibrahim

CONTACT

00201150007844shaimaa.ibrahim121@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher

Study Record Dates

First Submitted

March 4, 2025

First Posted

March 12, 2025

Study Start

March 1, 2025

Primary Completion

September 1, 2025

Study Completion

September 1, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

EG(1)