Clinical trial NCT06871475: The Effect Of Using Sticky Bone With Coronally Advanced Flap In Management Of Type 1 Gingival Recession
Official title: The Effect Of Using Sticky Bone With Coronally Advanced Flap In Management Of Type 1 Gingival Recession
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Gingival Recession, Localized
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 22
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Selected patients of both sexes with age range 25-45 years old.
2. Patients are systemically healthy based on questionnaire dental modification of Cornell index.
3. 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).
4. Buccal recession defects are classified RT1 according to Cairo's classification (2011).
5. Clinical indication and/or patient request for recession coverage.

Exclusion Criteria:

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

Primary outcomes:
measure: recession depth
timeFrame: changes in millimeters from base line up to 6 months
measure: thickness of keratinized gingiva
timeFrame: changes in biotype in millimeters from base line to follow up after 6 months
Secondary outcomes:
measure: Recession Width
timeFrame: changes in millimeters from base line to follow up after 6 months
measure: the height of keratinized gingiva
timeFrame: changes in millimeters from base line up to 6 months
measure: percentage of root coverage
timeFrame: changes in percentile from base line up to 6 months
measure: Probing pocket depth
timeFrame: changes in millimeters from base line up to 6 months
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Minia University
Study officials:
affiliation: Minia University
name: Mohamed AbdElmonem Ebrahem, Professor
role: STUDY_CHAIR
affiliation: Minia University
name: Ahmed Abdallah Khalil, professor
role: STUDY_CHAIR
affiliation: Minia University
name: AyaAllah Kamal Abd El-al, lecturer
role: STUDY_DIRECTOR
affiliation: Minia University
name: Shaimaa Mohamed Ibrahim
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Louis F. Rose, D. M. (2006). Surgical Therapies for the Treatment of Gingival Recession. Inside dentistry.
citation: 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.
citation: Hadziabdic, N. (2022). PRF and Sticky Bone as Regenerative Materials in Oral Surgery. IntechOpen. doi:10.5772/intechopen.108807
citation: 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.
citation: 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.
citation: 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.