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Comparison of traditional Flap and novel Flapless approach for Single stage dental Implants.

Comparative assessment of hard and soft tissue changes in flap and minimally invasive flapless approach in bone-level single-stage implant: A randomized controlled trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088972
Enrollment
46
Registered
2025-06-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Flap approach: Novel flap reflection approach is used. Control Intervention1: Minimally invasive flapless approach: Minimally invasive flapless approach using round rotatory diamond bur

Sponsors

DR VISHWA AMIN
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Periodontally healthy subjects. Nonsmokers. Age over 18 years. Agreed to follow-up visits for 6 months. Presence of a minimum of 2 mm of Keratinized Mucosa at the labial/Buccal aspects in the implant zone. Minimum crestal bone width 5-6mm (buccolingually). Bone architecture without undercuts and presence of 1 mm of bone buccolingual to the planned position in a favorable prosthetic situation from pre-operative CBCT. Subjects signed surgical consent forms.

Exclusion criteria

Exclusion criteria: Subjects with systemic diseases affecting the healing process. Uncontrolled or poorly controlled diabetes. Pregnant and lactating women. Radiation to the head and neck. Subjects requiring guided bone regeneration. Previous implant installation or bone grafting at the Surgical site.

Design outcomes

Primary

MeasureTime frame
1) Width of Keratinized Mucosa. 2) Marginal bone loss Timepoint: 1) The width of Keratinized Mucosa will be evaluated at baseline, 3 months, and 6 months postoperatively. 2) Marginal bone loss to be assessed: Baseline, 3-month and 6-month post-operatively using RadioVisioGraphy (RVG).

Secondary

MeasureTime frame
Wound healing index. Timepoint: The wound healing index will be evaluated at 1 week, 2 weeks, and 4 weeks post-surgery. ;Modified plaque index (mPI). and Modified Sulcus bleeding indexTimepoint: Modified plaque index (mPI) & Modified Sulcus bleeding index will be evaluated at 1 month, 3 months, and 6 months post-surgery.

Countries

India

Contacts

Public ContactDr Shivlal Vishnoi

Manubhai Patel Dental College and Hospital and ORI

vishnoi_shivlal@yahoo.com9586869196

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026